| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 05055273207071 | CPL4017 | DDB | Ceruloplasmin, Antigen, Antiserum, Control | 2 | CERULOPLASMIN (CPL) | ||
| 2 | 05055273203400 | GR2368 | KQF | Assay, Glutathione Reductase | 2 | GLUTATHIONE REDUCTASE (GLUT RED) | ||
| 3 | 05055273209587 | UP8113 | JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | TOTAL PROTEIN (UP) | ||
| 4 | 05055273207118 | LUN5048 | OHQ | Multi-Analyte Controls Unassayed | 1 | LIQUID CHEMISTRY PREMIUM - LEVEL 2 (LIQ CHEM PREMIUM 2) | ||
| 5 | 05055273207163 | LUL5093 | OHQ | Multi-Analyte Controls Unassayed | 1 | LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 1 (LIQ CHEM PREMIUM PLUS 1) | ||
| 6 | 05055273204322 | LO3999 | GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | ||
| 7 | 05055273203516 | GY1369 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GLYCEROL CONTROL (GLY CONTROL) | ||
| 8 | 05055273203066 | FA115 | JLG | Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids | 1 | Non-Esterified Fatty Acids (NEFA) | ||
| 9 | 05055273200164 | AL1205 | AL1205 | CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | ALANINE AMINOTRANSFERASE (ALT) | |
| 10 | 05055273217766 | AMH10516 | AMH10516 | The AMH Control Level 4 (AMH10516) is intended for use with in vitro diagnostic The AMH Control Level 4 (AMH10516) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 4 (AMH10516) is assayed with target values and is suitable for use on automated analysers.The AMH Control Level 4 (AMH10516) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AMH CONTROL LEVEL 4 (AMH CONTROL 4) |
| 11 | 05055273217667 | CQ10430 | CQ10430 | This product is intended for in vitro use, in the quality control of Cardiac Mar This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | CARDIAC CONTROL - LEVEL 2 (CRD CONTROL 2) |
| 12 | 05055273215205 | LE10175 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID FROZEN LIPID CONTROL - LEVEL 2 (LIQ LPD CONTROL 2) | ||
| 13 | 05055273215175 | BR10172 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1) | ||
| 14 | 05055273214338 | RX4045 | RX4045 | This is required for measuring reference electrode potential of an ion selective This is required for measuring reference electrode potential of an ion selective electrode module. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | REF SOLN |
| 15 | 05055273214307 | RP8398 | RP8398 | The Reagent Precision Test is used on the RX series clinical chemistry systems f The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | RABS |
| 16 | 05055273213966 | CH2656 | Enzymatic Clearance assay for the in vitro quantitative determination of LDL-cho Enzymatic Clearance assay for the in vitro quantitative determination of LDL-cholesterol in human serum and plasma. | MRR | System, Test, Low Density, Lipoprotein | 1 | DIRECT LDL-CHOLESTEROL (LDL) | |
| 17 | 05055273210378 | RX8106 | RX8106 | Antibacterial Detergent is used for cleaning the instrument probe and reaction cuvettes. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | ANTI-BACTERIAL DETERGENT (Detergent) |
| 18 | 05055273209389 | SA8396 | SA8396 | This product should be used in conjunction with RX daytona plus reagents to dilu This product should be used in conjunction with RX daytona plus reagents to dilute samples prior to assay. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | NS |
| 19 | 05055273209211 | LP8007 | MSJ | Apolipoproteins | 1 | APOLIPOPROTEIN A-I (APO A-I) | ||
| 20 | 05055273209204 | LP5047 | JIT | Calibrator, Secondary | 2 | APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2) | ||
| 21 | 05055273209181 | LO8305 | GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | ||
| 22 | 05055273209174 | LO8015 | GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | ||
| 23 | 05055273209143 | LM4005 | LM4005 | The product is intended for the quantitative in vitro determination of Lithium in serum. | NDW | Assay, Porphyrin, Spectrophotometry, Lithium | 2 | Li 2 |
| 24 | 05055273209020 | LAN4216 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM – LEVEL 2 (LIQ CHEM ASY PREMIUM 2) | ||
| 25 | 05055273208634 | CR8316 | CR8316 | The is intended for the quantitative in vitro diagnostic determination of Creati The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine | CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | CREA |
| 26 | 05055273208498 | CH8312 | MRR | System, Test, Low Density, Lipoprotein | 1 | DIRECT LDL-CHOLESTEROL (LDL) | ||
| 27 | 05055273208481 | CH8311 | For the quantitative in vitro determination of HDL Cholesterol in serum and plasma. | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | DIRECT HDL-CHOLESTEROL (HDL) | |
| 28 | 05055273208467 | CH8033 | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | DIRECT HDL-CHOLESTEROL (HDL) | ||
| 29 | 05055273208450 | CH8032 | MRR | System, Test, Low Density, Lipoprotein | 1 | DIRECT LDL-CHOLESTEROL (LDL) | ||
| 30 | 05055273208412 | CH1383 | Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cho Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cholesterol in human serum and plasma. | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | DIRECT HDL-CHOLESTEROL (HDL) | |
| 31 | 05055273208047 | DA4011 | DA4011 | The Cocaine assay is an in vitro diagnostic test for the qualitative and semi-qu The Cocaine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine (Cocaine Metabolite) in human urine. | DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | BZG |
| 32 | 05055273207958 | DA3127 | DA3127 | The Randox Cannabinoid Control - Level 1 is intended for use in the Quality Cont The Randox Cannabinoid Control - Level 1 is intended for use in the Quality Control of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. The Cannabinoid Control Level 1 contains the specific drug Cannabinoid. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | THC CONTROL 1 |
| 33 | 05055273207330 | IAS3118 | This product is intended for in vitro diagnostic use, in the quality control of This product is intended for in vitro diagnostic use, in the quality control of the accuracy of Immunoassays on clinical chemistry systems. Thismaterial can be used to monitor the control of accuracy or the control of reproducibility of immunoassays. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | IMMUNOASSAY SPECIALITY II - LEVEL 2 (IA SPECIALITY II LEV 2) | |
| 34 | 05055273207880 | DA2704 | DA2704 | The Randox Multidrug Calibrator Set is intended for use in the calibration of Me The Randox Multidrug Calibrator Set is intended for use in the calibration of Methamphetamine, Barbiturates, Cocaine Metabolite, Methadone and Opiate assays. | DKB,DLJ | Calibrators, Drug Mixture,Calibrators, Drug Specific | 2 | DOA CAL |
| 35 | 05055273207866 | DA2702 | DA2702 | The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-e The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. | DKB | Calibrators, Drug Mixture | 2 | EDDP CAL |
| 36 | 05055273207781 | RX4041 | RX4041 | The Randox RX daytona plus without ISE is a fully automated, random access, clin The Randox RX daytona plus without ISE is a fully automated, random access, clinical chemistry analyser completewith dedicated analyser software. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | RX daytona plus |
| 37 | 05055273207774 | RX4040 | RX4040 | The Randox RX daytona plus with ISE is a fully automated, random access, clinica The Randox RX daytona plus with ISE is a fully automated, random access, clinical chemistry analyser completewith dedicated analyser software. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | RX daytona plus |
| 38 | 05055273207644 | CG5023 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3) | ||
| 39 | 05055273207262 | IA3110 | This product is intended for in vitro diagnostic use, as assayed quality control This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2) | |
| 40 | 05055273207248 | LIA3108 | The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed for use in the quality control of quantitative assays statedin this package insert. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID IMMUNOASSAY PREMIUM - TRI-LEVEL (LIQ IA PREMIUM 1, 2 AND 3) | |
| 41 | 05055273206456 | TD3414 | TD3414 | For the quantitative in vitro determination of Valproic Acid in human serum | LEG | Enzyme Immunoassay, Valproic Acid | 2 | VPA |
| 42 | 05055273206173 | SE1086 | OHQ | Multi-Analyte Controls Unassayed | 1 | BOVINE PRECISION MULTI SERA - LEVEL 3 (BOV PREC CONTROL 3) | ||
| 43 | 05055273206111 | SA3854 | SA3854 | This product should be used in conjunction with RX series reagents to dilute sam This product should be used in conjunction with RX series reagents to dilute samples prior to assay | JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | NS |
| 44 | 05055273205091 | RP3857 | RP3857 | The Reagent Precision Test is used on the RX series clinical chemistry systems f The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system. | JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | RABS |
| 45 | 05055273204315 | LO3998 | GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | ||
| 46 | 05055273204049 | IT2692 | IT2692 | Liquid Protein Calibrators are an in vitro diagnostic product used for the calib Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of Alpha-1-Antitrypsin, Alpha-1-Acid glycoprotein, IgA, IgG and IgM assays that require sample pre-dilution. | JIX | Calibrator, Multi-Analyte Mixture | 2 | SP CAL (LIQ) |
| 47 | 05055273204032 | IT2691 | IT2691 | Liquid Protein Calibrators are an in vitro diagnostic product used for the calib Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, Ceruloplasmin, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, RF and Transferrin assays. | JIX | Calibrator, Multi-Analyte Mixture | 2 | SP CAL (LIQ) |
| 48 | 05055273203783 | HN1530 | The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target valu The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | HUMAN ASSAYED MULTI-SERA/ASSAYED CHEMISTRY PREMIUM PLUS - LEVEL 2 (HUM ASY CONTR | |
| 49 | 05055273202458 | EV3550 | EV3550 | Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser. | DKB | Calibrators, Drug Mixture | 2 | DOA CAL |
| 50 | 05055273202397 | EV3542 | EV3542 | The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative determination of the parent molecule and metabolites of drugs in human urine. They are competitive enzyme immunoassays. | DIO,DJR,DKZ,DIS,JXM,LDJ,DJG,LCM | Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Methadon Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Phencyclidine | 2 | DOA |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 10052569138479 | TRUEtrack PRE-PACK | A4089-75 | Health Mart PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 2 | 10021292008625 | TRUEtrack PRE-PACK | A4027-75 | Preferred Plus Pharmacy TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 3 | 10021292008618 | TRUEtrack PRE-PACK | A4011-75 | GOOD NEIGHBOR PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 4 | 10021292006874 | TRUEtrack PRE-PACK | A4088-75 | HealthWise PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 5 | 10021292006867 | TRUEtrack PRE-PACK | A4054-75 | Sunmark TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 6 | 10021292006843 | TRUEtrack PRE-PACK | A4H01-75 | TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 7 | 09421902348112 | 107253 | HB510Ar | The lypholised Hemoglobin A1c Linearity controls are prepared from human blood a The lypholised Hemoglobin A1c Linearity controls are prepared from human blood and contain normal hemoglobin, preservatives and stabilizers. The controls are formulated to give enhanced stability.The Lyophilized Hemoglobin A1c Linearity Controls are intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols setup within individual clinical laboratories. | ExtendSure | CANTERBURY SCIENTIFIC LIMITED |
| 8 | 09421902348099 | B12397 | The liquid Hemoglobin A1c Control kit contains 12 vials each of level 1 and leve The liquid Hemoglobin A1c Control kit contains 12 vials each of level 1 and level 2 controls which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures. | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | |
| 9 | 09421902348082 | HB510 | The lypholised Hemoglobin A1c Linearity kit contains 1 vial each of level 1, 2, The lypholised Hemoglobin A1c Linearity kit contains 1 vial each of level 1, 2, 3, 4 and 5 controls which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures. | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | |
| 10 | 09421902348075 | HB710SBAr | The lypholised Hemoglobin A1c Control kit contains 4 vials each of level 1 and l The lypholised Hemoglobin A1c Control kit contains 4 vials each of level 1 and level 2 controls which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures. | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | |
| 11 | 09421902348068 | 220232 | Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reco Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reconstituted), 4 Vials of Level 2 Controls (0.25mL reconstituted), 1 Package Insert | TOSOH | CANTERBURY SCIENTIFIC LIMITED | |
| 12 | 09421902348006 | B12396 | The liquid Hemoglobin A1c Control kit contains 2 vials each of level 1 and level The liquid Hemoglobin A1c Control kit contains 2 vials each of level 1 and level 2 controls which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures. | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | |
| 13 | 08809317540566 | FREND Vitamin D Linearity Kit | FLK-VTD | FREND™ TSH Linearity Kit is intended for use as an assayed linearity material fo FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | FREND | NANOENTEK, INC. |
| 14 | 08809317540559 | FREND TSH Linearity Kit | FLK-TSH | FREND™ TSH Linearity Kit is intended for use as an assayed linearity material fo FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | FREND | NANOENTEK, INC. |
| 15 | 08809317540542 | FREND Testosterone Linearity Kit | FLK-TES | FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity ma FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity material for the testosterone on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ Testosterone Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution | FREND | NANOENTEK, INC. |
| 16 | 08809317540535 | FREND PSA Plus Linearity Kit | FLK-PSA | FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity materi FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity material for the prostate-specific antigen (PSA) on the FREND™ System. The Linearity kit is for the FREND™ System only.FREND™ PSA Plus Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | FREND | NANOENTEK, INC. |
| 17 | 08809317540528 | FREND Free T4 Linearity Kit | FLK-FT4 | FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity materia FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity material for the free thyroxine (Free T4) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ Free T4 Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | FREND | NANOENTEK, INC. |
| 18 | 08809301168073 | GT-C03 | GlucoTrack Solution Level 3 | PHILOSYS CO., LTD | ||
| 19 | 08809301168066 | GT-C02 | GlucoTrack Solution Level 2 | PHILOSYS CO., LTD | ||
| 20 | 08809301168059 | GT-C01 | GlucoTrack Solution Level 1 | PHILOSYS CO., LTD | ||
| 21 | 08809301162217 | PC003-US | Pip Control Solution High | PHILOSYS CO., LTD | ||
| 22 | 08809301162200 | PC002-US | Pip Control Solution Normal | PHILOSYS CO., LTD | ||
| 23 | 08809301162194 | PC001-US | Pip Control Solution Low | PHILOSYS CO., LTD | ||
| 24 | 08809301162057 | PC-001 | Gmate® Control Solution Level 1 | PHILOSYS CO., LTD | ||
| 25 | 08809301162026 | PC-003 | Gmate® Control Solution Level 3 | PHILOSYS CO., LTD | ||
| 26 | 08809301162019 | PC-002 | Gmate® Control Solution Level 2 | PHILOSYS CO., LTD | ||
| 27 | 08809115908971 | IGM-0021B | Blood Glucose Monitoring System | Element™Plus Meter | OSANG HEALTHCARE CO., LTD. | |
| 28 | 08809115908452 | IGM-0021B | Blood Glucose Monitoring System | Element™ Meter | OSANG HEALTHCARE CO., LTD. | |
| 29 | 08809115906533 | IGM-1003F | blood glucose meter and test strip control solution-level 3 | Oh'Care Lite Smart Glucose control solution-Level 3 | OSANG HEALTHCARE CO., LTD. | |
| 30 | 08809115906526 | IGM-1003F | blood glucose meter and test strip control solution-Level 2 | Oh'Care Lite Smart Glucose control solution-Level 2 | OSANG HEALTHCARE CO., LTD. | |
| 31 | 08809115906519 | IGM-1003F | blood glucose meter and test strip control solution level 1 | Oh'Care Lite Smart Glucose control solution-Level 1 | OSANG HEALTHCARE CO., LTD. | |
| 32 | 08806679002718 | CFPC-15 | CFPC-15 | ichroma™ iFOB | BODITECH MED INC. | |
| 33 | 08806128340064 | AGM-4000 | Embrace Pro Blood Glucose Test Meter | ALL MEDICUS CO.,LTD. | ||
| 34 | 08806128340019 | AGM-4000 | Embrace Pro Blood Glucose Test Strip | ALL MEDICUS CO.,LTD. | ||
| 35 | 08806128340002 | AGM-4000 | Embrace Pro Control Solution | ALL MEDICUS CO.,LTD. | ||
| 36 | 08718734961406 | 025.000.005 | GlucoLin is an assayed glucose control intended for professional use in the veri GlucoLin is an assayed glucose control intended for professional use in the verification of the linearity of the HemoCue® Glucose systems.A box of GlucoLin contains 5 levels of control material:GlucoLin XLow: 08718734961352GlucoLin Low: 08718734961369GlucoLin Normal: 08718734961376GlucoLin High: 08718734961383GlucoLin XHigh: 08718734961390 | GlucoLin | EUROTROL B.V. | |
| 37 | 08718734960935 | 180.013.002 | Eurotrol GlucoTrol-AQ is an assayed glucose control intended for professional us Eurotrol GlucoTrol-AQ is an assayed glucose control intended for professional use in the verification of the precision and accuracy of the HemoCue Glucose 201 analyzer.A box of Eurotrol GlucoTrol-AQ contains 2 levels of control material:GlucoTrol-AQ Low (1): 08718734961536GlucoTrol-AQ High (3): 08718734961543 | Eurotrol GlucoTrol-AQ | EUROTROL B.V. | |
| 38 | 08718734960645 | AlbuTrol Level 2 | 189.002.002 | Eurotrol AlbuTrol® is an assayed albumin control intended for professional use i Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin. | Eurotrol AlbuTrol | EUROTROL B.V. |
| 39 | 08718734960621 | AlbuTrol Level 1 | 189.001.002 | Eurotrol AlbuTrol® is an assayed albumin control intended for professional use i Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin. | Eurotrol AlbuTrol | EUROTROL B.V. |
| 40 | 08718734960607 | GlucoTrol-NG Level 4 | 170.004.002 | Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional us Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems. | Eurotrol GlucoTrol-NG | EUROTROL B.V. |
| 41 | 08718734960584 | GlucoTrol-NG Level 3 | 170.003.002 | Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional us Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems. | Eurotrol GlucoTrol-NG | EUROTROL B.V. |
| 42 | 08718734960560 | GlucoTrol-NG Level 2 | 170.002.002 | Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional us Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems. | Eurotrol GlucoTrol-NG | EUROTROL B.V. |
| 43 | 08426951301706 | 00009800022 | 00009800022 | 1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tube 1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. HemosIL Acustar ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. | HemosIL AcuStar Anti-B2GPI Domain 1 Controls | INSTRUMENTATION LABORATORY COMPANY |
| 44 | 08426950928782 | 701352 | 1. QUANTA Flash Calprotectin Low Control: Two (2) barcode labeled tubes containi 1. QUANTA Flash Calprotectin Low Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain recombinant calprotectin with stabilizers and preservatives. 2. QUANTA Flash Calprotectin High Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain recombinant calprotectin with stabilizers and preservatives. | QUANTA Flash® Calprotectin Controls | INOVA DIAGNOSTICS, INC. | |
| 45 | 08426950869320 | 701347 | 1. QUANTA Flash RF IgA Negative Control: Two (2) barcode labeled tubes containin 1. QUANTA Flash RF IgA Negative Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgA in stabilizers and preservatives.2. QUANTA Flash RF IgA Postitive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgA in stabilizers and preservatives. | QUANTA Flash RF IgA Controls | INOVA DIAGNOSTICS, INC. | |
| 46 | 08426950845263 | 701342 | 1. QUANTA Flash RF IgM Negative Control: Two (2) barcode labeled tubes containin 1. QUANTA Flash RF IgM Negative Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgM in stabilizers and preservatives.2. QUANTA Flash RF IgM Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgM in stabilizers and preservatives. | QUANTA Flash RF IgM Controls | INOVA DIAGNOSTICS, INC. | |
| 47 | 08426950793175 | 701332 | 1. QUANTA Flash HMGCR Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash HMGCR Negative Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to HMGCR in stabilizers and preservatives.2. QUANTA Flash HMGCR Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to HMGCR in stabilizers and preservatives. | QUANTA Flash® HMGCR Controls | INOVA DIAGNOSTICS, INC. | |
| 48 | 08426950766995 | 701297 | 1. QUANTA Flash LKM-1 Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash LKM-1 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to LKM-1 in stabilizers and preservatives.2. QUANTA Flash LKM-1 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to LKM-1 in stabilizers, and preservatives." | QUANTA Flash® LKM-1 Controls | INOVA DIAGNOSTICS, INC. | |
| 49 | 08426950730095 | 701302 | 1. QUANTA Flash M2 (MIT3) Negative Control: Two (2) barcode labeled tubes contai 1. QUANTA Flash M2 (MIT3) Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to M2 (MIT3) in stabilizers and preservatives.2. QUANTA Flash M2 (MIT3) Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to M2 (MIT3) in stabilizers, and preservatives. | QUANTA Flash® M2 (MIT3) Controls | INOVA DIAGNOSTICS, INC. | |
| 50 | 08426950724483 | 701327 | 1. QUANTA Flash Scl-70 Negative Control: Two (2) barcode labeled tubes containin 1. QUANTA Flash Scl-70 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Scl-70 in stabilizers and preservatives.2. QUANTA Flash Scl-70 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Scl-70 in stabilizers, and preservatives. | QUANTA Flash® Scl-70 Controls | INOVA DIAGNOSTICS, INC. |