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Catalogue

Product catalog summary
Overview of Biolis Clinical Chemistry Analyzers:
Biolis 50i and Biolis 30i are automated clinical chemistry analyzers certified by Futura System Group s.r.l., designed for high performance in chemical chemistry tests. They feature dedicated packaging with barcodes.
Biolis 50i Features:
  • Dimensions: W1050 x D750 x H1145 mm; Weight: 300 kg
  • Power Input: AC100/115/230V±10%, 50/60Hz
  • Ambient Conditions: 15°C - 30°C
  • Automatic sample pre-dilution and reagent tray refrigeration under 10°C
  • Capacity for 72 samples on board with easy touch screen operation
  • Throughput: 480 tests/hour for photometry, 580 tests/hour with ISE
Biolis 30i Features:
  • Dimensions: 80 x 67 x 55.5 cm; Weight: 95 kg
  • Power Input: 100/115/230 volt (50-60 Hz)
  • Ambient Conditions: 15°C – 30°C
  • Compact design with space-saving features and easy-to-use software
  • Throughput: 270 tests/hour, 450 tests/hour with ISE
Reagents and Controls:
  • Various reagents for clinical chemistry, including Total and Prostatic Acid Phosphatase, Albumin, Alkaline Phosphatase, ALT GPT, AST GOT, Alpha Amylase, and Bilirubin
  • Special chemistry reagents and controls for ACE, β-HBA, Total Bile Acids, 25 OH-Vitamin D, and more
  • Calibrators and controls for clinical chemistry, including Chemistry Calibrator, Chemistry Control N and P, HDL-LDL Cholesterol Calibrator, and Lipidic Control
Wash Solutions:
  • Daily and extra wash solutions for cuvettes and flow cells
  • Surfactant for hydraulic circuits and detergent solutions for systemic wash
Certifications:
  • ISO 9000 - 13485 certified
Product Specifications: The document lists various products such as β-HBA Low Control, Total Bile Acids Control, 25 OH-Vitamin D Control Set, and others. Each product is described with its intended use, such as quantitative assays on serum and plasma, and the type of control or calibrator it provides.
Packaging and Stability: Products are available in different packaging sizes, often in lyophilized or liquid form. Stability information, such as open vial stability for ammonia controls, is provided.
Instrument Compatibility: Products are compatible with various automated analyzers, including Biolis, Hitachi, Dirui, Beckman Coulter, and Olympus models. Specific barcoding information is provided for certain products to ensure compatibility with these instruments.
Reagents and Controls Reference Table: A comprehensive table lists reagents, calibrators, and controls with their reference numbers, packaging details, and whether standards or calibrators are included in the kit.
Critical Information:
  • Exigencies: The document emphasizes the need for specific calibrators and controls for accurate quantitative assays.
  • Parameters and Limitations: Details on the volume and type of reagents required for different assays are provided, along with any limitations regarding kit contents.
  • Best Practices: Recommendations for using specific barcoded vials for compatibility with automated analyzers are highlighted to ensure accurate and efficient testing.
Calibrators and Controls:
  • 25-(OH) D Levels: Control set for assessing Vitamin D sufficiency in serum or plasma.
  • CI+OX Calibrator: Used for quantitative determination of Oxalate and Citric acid in urine and spermatic liquid.
  • Ethanol Controls: High and low liquid controls for ethanol quantitative UV assay on serum, whole blood, and urine.
  • G6PDH Controls: Lyophilized controls for Glucose-6-Phosphate Dehydrogenase determination.
  • Ammonia Controls: Liquid controls with a stability of 30 days at 2-8°C.
Special Chemistry:
  • Multidrug Controls: For urine with low and high cut-offs for various drugs including AMP, COC, MTD, and others.
  • Therapeutic Drug Monitoring (TDM): Includes reagents, calibrators, and controls for drugs like Carbamazepine, Digoxin, and Valproic Acid.
Immunoturbidimetry Reagents:
  • Anti Streptolysin O (ASO), C Reactive Protein (CRP), and Rheumatoid Factors (RF): Quantitative immunoturbidimetric tests with stable, ready-to-use reagents.
  • Direct HbA1c: For Glyco-Haemoglobin HbA1c determination using a monoclonal antibody latex coated method.
  • Microalbumin, Apolipoprotein A1, B, and Lipoprotein (a): Quantitative tests with multipoint calibration curves.
Coagulation:
  • Thromboplastin "L": Liquid rabbit brain Thromboplastin for Prothrombin Time determination.
  • APTT SI + Calcium Chloride: Reagents for Activated Partial Thromboplastin Time.
  • Clauss Fibrinogen: Quantitative assay with lyophilized Thrombin reagent and Imidazole Buffer.
Conclusion: The document provides comprehensive details on the packaging, stability, and application of various reagents and controls essential for clinical and special chemistry assays, ensuring accurate and reliable laboratory results.
Lyophilized Human Plasma Products:
  • Fibrinogen Calibrator (CH020): Used to calibrate Fibrinogen assays according to Clauss. Stability is 4 hours at 2-8°C.
  • PT Calibration Curve (CH021): Contains 4 levels of PT Calibrans for establishing PT Calibration Curves. Stability is 1 hour after reconstitution.
  • Coagulation Calibrator (CH022): Used as a reference plasma for various coagulation factors. Stability is 2 hours at 2-8°C.
  • Normal and Abnormal Control Plasma (CH004, CH005): Provide reference values for PT, APTT, Fibrinogen, and other parameters. Stability is 24 hours at 2-8°C.
Reagents and Calibrators:
  • Thromboplastin "L" (CH111): Liquid reagent for determining Prothrombin Time (PT). Stability is 60 days at 2-8°C.
  • APTT SI + Calcium Chloride (CH224): Ready-to-use reagents for Activated Partial Thromboplastin Time. Includes phospholipids and silica contact activator.
  • Clauss Fibrinogen Assays (CH100A, CH035A, CH050A): Kits include lyophilized Thrombin reagent and Imidazole Buffer. Stability varies based on storage conditions.
  • Kaolin Suspension (CH008): Auxiliary reagent for manual assays of Clauss Fibrinogen.
Special Plasmatic Proteins:
  • Radial Immunodiffusion (RID) Products: Quantitative methods for various proteins such as Immunoglobulins, Antithrombin III, and Apolipoproteins using Mancini's method.
  • Bence Jones Protein RID (IR021): Qualitative method for urinary proteins using double immunodiffusion.
Compatibility and Reference Tables:
  • Tables provide compatibility of reagents with different coagulometers and reference information for product packaging and stability.
Coagulation Products:
  • Coagulation Calibrator (CH021): Lyophilized human plasma for rehydration with distilled water, stable for 2 hours at 2-8°C. Used as reference plasma for various coagulation factors and proteins.
  • Normal Control Plasma (CH022): Lyophilized human plasma, stable for 24 hours at 2-8°C. Provides reference values for PT, APTT, Fibrinogen, and more across various coagulometers.
  • Abnormal Control Plasma (CH004): Similar to Normal Control Plasma but for abnormal ranges, stable for 24 hours at 2-8°C.
  • Thromboplastin "L" (CH005): Liquid rabbit brain thromboplastin for PT determination, stable for 60 days at 2-8°C. Sensitive to deficiencies in extrinsic pathway factors.
  • APTT SI + Calcium Chloride (CH111): Ready-to-use reagents for APTT, including phospholipids and silica contact activator.
  • Clauss Fibrinogen (CH224): Quantitative assay with lyophilized thrombin reagent, stable for varying durations depending on storage conditions.
  • Kaolin Suspension (CH008): Auxiliary reagent for manual assays of Clauss Fibrinogen.
  • Fibrinogen Calibrator (CH020): Lyophilized plasma for rehydration, stable for 4 hours at 2-8°C, used for calibrating fibrinogen assays.
  • PT Calibration Curve (CH021): Lyophilized plasma for establishing PT calibration curves, stable for 1 hour after reconstitution.
Serology Products:
  • Salmonella Typhi and Paratyphi Antigens: Coloured inactive bacterial suspensions for quantitative and qualitative antibody determination via agglutination tests, according to Widal.
  • Proteus and Brucella Antigens: Similar suspensions for antibody determination associated with Rickettsie and Brucella, using agglutination tests.
Special Chemistry Products:
  • Oxalate Assays: Quantitative colorimetric assays for oxalate in urine, including purification powder and standard solutions.
  • Pyruvate Assays: Quantitative UV assays for pyruvate in whole blood, with options for automation.
  • Pyruvate Kinase: Kinetic UV determination in serum and erythrocytes, with calibrator and diluent included.
  • Urinary Stones: Qualitative colorimetric determination of various compounds in renal and urinary stones.
  • 25 OH-Vitamin D: Quantitative determination of Vitamin D levels in serum or plasma, with a complete kit for automated analyzers.
Serology Products:
  • Brucella Abortus and Suis: These are colored inactive bacterial suspensions used for quantitative antibody determination via agglutination tests, following Wright's method.
  • Widal and Widal-Wright Kits: These kits are designed for the quantitative and qualitative determination of antibodies against Salmonella and Brucella species using tube and slide tests.
  • Control Kits: Include positive and negative controls for Salmonella, Brucella, and Proteus, used alongside Widal Wright serodiagnosis tests.
Special Chemistry Products:
  • Oxalate and Pyruvate Assays: These involve quantitative colorimetric and UV assays for detecting oxalate in urine and pyruvate in whole blood, respectively.
  • Urinary Stones Analysis: A qualitative colorimetric method for identifying various compounds in renal and urinary stones.
  • 25 OH-Vitamin D: A kit for the quantitative determination of Vitamin D levels in serum or plasma.
Rapid Tests:
  • Pregnancy and Infectivity Tests: Include rapid chromatographic tests for detecting hCG, Helicobacter Pylori, Rotavirus, Adenovirus, Mononucleosis, Tuberculosis, and various Streptococcus and Legionella antigens.
Coagulation Products:
  • Thromboplastin and APTT Reagents: Used for determining Prothrombin Time and Activated Partial Thromboplastin Time, with specific stability and sensitivity parameters.
  • Fibrinogen Assays: Include Clauss Fibrinogen quantitative assays and related calibrators and reagents for accurate measurement.
Key Specifications:
  • Stability and storage conditions are specified for each product, ensuring optimal performance and reliability.
  • Packaging details are provided, indicating the volume and number of tests each kit can perform.
Recommendations:
  • Ensure proper storage conditions as specified for each product to maintain stability and efficacy.
  • Follow the detailed instructions for reconstitution and usage to achieve accurate results.
Product Specifications and Stability:
1. Normal and Abnormal Control Plasma: Lyophilized human plasma for rehydration with distilled water, stable for 24 hours at 2-8°C. Used for PT, APTT, Fibrinogen, TT, Derived Fibrinogen, and Antithrombin Xa reference values across various coagulometers.
2. Thromboplastin "L": Liquid rabbit brain Thromboplastin for Prothrombin Time (PT) determination, stable for 60 days at 2-8°C. Sensitive to deficiencies in extrinsic pathway factors.
3. APTT SI + Calcium Chloride: Ready-to-use reagents for Activated Partial Thromboplastin Time, including phospholipids and silica contact activator.
4. Clauss Fibrinogen: Quantitative assay with lyophilized Thrombin reagent and Imidazole Buffer, stability varies by storage temperature.
5. Kaolin Suspension: Auxiliary reagent for manual Clauss Fibrinogen assays.
6. Fibrinogen Calibrator: Lyophilized plasma for calibration, stable for 4 hours at 2-8°C.
7. PT Calibration Curve: Lyophilized plasma for establishing PT Calibration Curve, stable for 1 hour post-reconstitution.
8. Coagulation Calibrator: Lyophilized plasma for calibration, stable for 2 hours at 2-8°C.
Special Chemistry and Rapid Tests:
1. Oxalate and Pyruvate Assays: Quantitative assays using colorimetric and UV methods for urine and whole blood.
2. Urinary Stones: Qualitative colorimetric determination of various compounds in renal and urinary stones.
3. 25 OH-Vitamin D: Quantitative determination in serum or plasma for Vitamin D sufficiency assessment.
4. Rapid Tests: Chromatographic lateral flow tests for cardiac markers (CK-MB, Myoglobin, Troponin I), fecal occult blood, IgE, microalbumin, and calprotectin.
Controls and Consumables:
1. Positive Controls: Swabs for various pathogens including Clostridium Difficile, Campylobacter, Giardia Lamblia, and viruses.
2. Consumables: Includes pipette tips, sample cups, and thermic paper.
3. Urine Tests: Reagent strips for multiple parameters in urine analysis.
Company Information:
Futura System Group s.r.l. provides detailed contact information and emphasizes compliance with MEDDEV guidelines for reporting medical device incidents.
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Catalog excerpts

Catalogue-1

AllMll chilli Catalogue Diagnostics and Reagents for Clinical Laboratories

 Open the catalog to page 1
Catalogue-2

Clinical Chemistry Biolis 50i - Clinical Chemistry analyzer 2 Biolis 30i - Clinical Chemistry analyzer 3 Vial / Instrument Reference Table 9 Reagents, Calibrators and Controls Reference Table 10 Special Chemistry Drugs of Abuse (DOA) liquid Reagents for Urine 16 Drugs of Abuse (DOA) Calibrators 16 Drugs of Abuse (DOA) Controls 17 Therapeutic Drug Monitoring (TDM) Reagents, Calibrators and Controls 17 Reagents, Calibrators and Controls Reference Table Reagents, Calibrators and Controls / Liquid Coagulation Line 24 Reagents, Calibrators and Controls Reference Table 25 Reagents Coagulometers Compatibility...

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Catalogue-3

Fully Automated Clinical Analyzer Biolis 50i is an automated Clinical analyzer with higher test performance and operability for Chemical Chemistry tests. Futura System Group s.r.l. has certified all its reagents line on Biolis 50i and provides dedicated packaging with barcode. Power input AC100/115/230V±10%, 50/60Hz Voltage fluctuation: Less than 10% Ambient conditions 480 tests/hour for photometry 580 tests/hour with ISE Main features • Automatic Sample’s Pre-dilution • Reagent tray: R1: 36 position; R2: 35 position. • Reagent Tray Refrigeration under 10 degree • Easy touch screen operation...

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Catalogue-4

Fully Automated Clinical Analyzer Biolis 30i Biolis 30i is the latest automated analyser for Chemical Chemistry model of Biolis series. It is a fully automated, bench-top use clinical analyser developed and manufactured in Japan. New functions has been developed as Sample clot detection, Crash prevention. Futura System Group s.r.l. has certified all its reagents line on the instrument. 270 tests/hour 450 tests/hour with ISE Main features • Automatic Sample’s Pre-dilution • Reagent tray: R1: 36 position; R2: 35 position. • Reagent tray Cooling temperature: 8-12°C • 30 samples on board for samples...

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Catalogue-5

Clinical Chemistry Reagents CLINICAL CHEMISTRY Product Total and Prostatic Acid Phosphatase Increasing kinetic colorimetric method according to Hillmann. Prefilled Buffer in 2 mL vials, Tartrate reagent liquid and ready to use, Substrate Fast Red as tablets to dissolve in the Buffer. Working Solution stability of 2 days at 2-8° C. Specific for serum (avoid plasma). Chemical colorimetric method with Bromcresol Green (BCG), reading in end point. Stable, liquid and ready to use monoreagent. Sample: serum or plasma. Standard (1x5 ml) liquid and ready to use included. Alkaline Phosphatase Increasing...

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Catalogue-6

Clinical Chemistry Chemical colorimetric method vwlh Arsenazo III, reading in end point. Stable, liquid and ready to use monoreagent. Sample: serum, plasma or diluted urine. Standard [1x10 ml) liquid and ready to use included. Chemical colorimetric method wth Mercurious Thiocyanate, reading in end point. Stable, 3006 6x50 ml liquid and ready to use monoreagent. Sample: serum, plasma, cerebrospinal fluid (CSF) HH30Q9 6x60 ml Or diluted urine. Standard (1x10 ml) liquid and ready to use included- B24-3009 6x40 ml Total Cholesterol Enzymatic colorimetric method according toTrinder, reading in end...

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Catalogue-7

Clinical Chemistry Increasing Kinetic colorimetric method according to Jaffe (alkaline pic rate) without dcproteimzation. Stable, liquid and ready to use reagents (4+1 ratio). Can be used as two-reagents for automation or as mororeagent preparing a working solution (stability of 5 hours at 15-25° C). Sample' serum plasma or diluted urine. Standard (1x10 ml) liquid and ready to use included. Enkinaticcolorimetricmetlod according to Trinder, reading in end point. Stable, liquid and ready to use monoreagent Sample' serum plasma ordiluBd urine Standard (1 x5 ml) liquid and ready to use included....

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Catalogue-8

Ref PackagingHomocysteine Enzymatic Enzyme cycling method, kinetic reeding in UV. Stable, liquid and ready to use HH7G71 R1 1x30 ml + R2 1x5 ml reagents. Sample: serum or plasma. Calibrators, liquid and ready to use, are B24-7071 R1 2x15 ml+ R2 1x5 ml included (LIV (0 gmoliL] 1x3 ml + LIV(28|jmoliL] 1x3 ml). Chemical turbidimetnc method with Tetraphenylborate, reading In end point. Stable, 3502 1x50 ml liquid and ready to use monoreagent. Sample: serum ot heparinized plasma. HH3503 4x€0 ml Standard (1x5 ml) liquid and ready to use included. B24-35Q3 6x40 mlPhosphorus Chemical UV method with Ammonium...

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Catalogue-9

Clinical Chemistry Calibrators and Controls Product Product CLINICAL CHEMISTRY SPECIAL CHEMISTRY Calibrators and Controls Calibrators and Controls Ref Packaging Ref Packaging ACE Calibrator Iyo Chemistry Calibrator Lyophilized calibrator for Angiotensin converting Enzyme (ACE) quantitative kinetic Multi parametric calibrator for clinical chemistry (enzymes, substrates and colorimetric assay FAPGG (N-[3-(2-furyl)acryloyl]-L-phenylalanylglycylglycine) method on electrolytes). Human matrix. Lyophilized. Chemistry Control N Iyo ACE Elevated Control Lyophilized control Angiotensin Converting Enzyme...

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Catalogue-10

Clinical Chemistry Vial / Instrument Reference Table REF Packaging The Reagents are distributed in standard round vials for general purpose and in special dedicated and barcoded vials for Automatic Analyzers Instruments. Products with Ref HHxxx : Vial for: Vials for: 1,8 cm Beckman Coulter Olympus 3,4 cm Products with code HH xxxx are barcoded for Biolis 50i and for Hitachi 911 /912 /917 on request 3,4 cm Products with code B24-xxxx are barcoded for Biolis 24i and Biolis 30i and fit the reagent plate at 36 positions.

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Catalogue-11

Clinical Chemistry Reagents, Calibrators and Controls Reference Table Total and Pnoatatlc Acid Phosphatase 2077 i9Bur0r*jmi na 0010 4310-5010 Alkaline Phosphatase Alpha Amylase Total Bilirubin Total Bilirubin Direct Bilirubin Direct Bilirubin Total Cholesterol Direct LDLCholesterol HHT068 RI 1 *46 ml * R2 1*12 ml [*ltnsu.milM<><■ Ur wilt *snmjtlwt«td* 6020 B24-7888 fil 2x24 ml + R2 2* G ml »lfc flsimsl 140 flr (It <i8,t icmril 1n;i or«r BOZO

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Catalogue-12

Clinical Chemistry Reagents, Calibrators and Controls Reference Table Creatinine Enzymatic Glyco Haemoglobin Iron Ferene TIBC - Total Iron Binding Capacity a* Rl Iill0mi + n2 irKar na Ups te Color 1734 ri me mi mi usiri na intiuJMi nihaut MiG-saiD Magnesium hmmus (MO ml norm shi 40iO.«iO E 74- S' 01 SiiG mi Not influx n t-i» kfl firMO A3i0-S0l3 Homocysteine Enzymatic RHtoti ri 1 xio mi r i ixs m cm 6 3mi. c*r j a )m u» c*t .1 m* m soi2(uq) Total Protein Uric Acid

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