| 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 | 08426950907220 | 701351 | 1. QUANTA Flash Calprotectin Calibrator 1: Two (2) barcode labeled tubes contain 1. QUANTA Flash Calprotectin Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain recombinant calprotectin with stabilizers and preservatives. 2. QUANTA Flash Calprotectin Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain recombinant calprotectin with stabilizers and preservatives. 3. QUANTA Flash Calprotectin Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain recombinant calprotectin with stabilizers and preservatives. | QUANTA Flash® Calprotectin Calibrators | INOVA DIAGNOSTICS, INC. | |
| 2 | 08426950845256 | 701341 | 1. QUANTA Flash RF IgM Calibrator 1: Two (2) barcode labeled tubes containing 0. 1. QUANTA Flash RF IgM Calibrator 1: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgM in stabilizers and preservatives.2. QUANTA Flash RF IgM Calibrator 2: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgM in stabilizers and preservatives. | QUANTA Flash RF IgM Calibrators | INOVA DIAGNOSTICS, INC. | |
| 3 | 08426950835196 | 701346 | 1. QUANTA Flash RF IgA Calibrator 1: Two (2) barcode labeled tubes containing 0. 1. QUANTA Flash RF IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgA in stabilizers and preservatives.2. QUANTA Flash RF IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgA in stabilizers and preservatives. | QUANTA Flash RF IgA Calibrators | INOVA DIAGNOSTICS, INC. | |
| 4 | 08426950793168 | 701331 | 1. QUANTA Flash HMGCR Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash HMGCR Calibrator 1: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to HMGCR in stabilizers and preservatives.2. QUANTA Flash HMGCR Calibrator 2: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to HMGCR in stabilizers and preservatives. | QUANTA Flash® HMGCR Calibrators | INOVA DIAGNOSTICS, INC. | |
| 5 | 08426950766988 | 701296 | 1. QUANTA Flash LKM-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash LKM-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives.2. QUANTA Flash LKM-1 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives.3. QUANTA Flash LKM-1 Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives. | QUANTA Flash® Lkm-1 Calibrators | INOVA DIAGNOSTICS, INC. | |
| 6 | 08426950729938 | 701301 | 1. QUANTA Flash M2 (MIT3) Calibrator 1: Two (2) barcode labeled tubes containing 1. QUANTA Flash M2 (MIT3) Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to M2 (MIT3) in stabilizers and preservatives.2. QUANTA Flash M2 (MIT3) Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to M2 (MIT3) in stabilizers and preservatives.3. QUANTA Flash M2 (MIT3) Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to M2 (MIT3) in stabilizers and preservatives. | QUANTA Flash® M2 (MIT3) Calibrators | INOVA DIAGNOSTICS, INC. | |
| 7 | 08426950724490 | 701326 | 1. QUANTA Flash Scl-70 Calibrator 1: Two (2) barcode labeled tubes containing 0 1. QUANTA Flash Scl-70 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Scl-70 in stabilizers and preservatives. 2. QUANTA Flash Scl-70 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Scl-70 in stabilizers and preservatives. | QUANTA Flash® Scl-70 Calibrators | INOVA DIAGNOSTICS, INC. | |
| 8 | 08426950622185 | 701126 | 1. QUANTA Flash CCP3 Calibrator 1: Two (2) barcode labeled tubes containing 0.7 1. QUANTA Flash CCP3 Calibrator 1: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to CCP3 in stabilizers and preservatives. 2. QUANTA Flash CCP3 Calibrator 2: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to CCP3 in stabilizers and preservatives. | QUANTA Flash® CCP3 Calibrators | INOVA DIAGNOSTICS, INC. | |
| 9 | 08426950601913 | 701176 | 1. QUANTA Flash dsDNA Calibrator 1: Two (2) barcode labeled tubes containing 0.7 1. QUANTA Flash dsDNA Calibrator 1: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to dsDNA in stabilizers and preservatives. 2. QUANTA Flash dsDNA Calibrator 2: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to dsDNA in stabilizers and preservatives. | QUANTA Flash® dsDNA Calibrators | INOVA DIAGNOSTICS, INC. | |
| 10 | 08426950597049 | 701146 | 1. QUANTA Flash Ro60 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash Ro60 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro60 in stabilizers and preservatives. 2. QUANTA Flash Ro60 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro60 in stabilizers and preservatives. | QUANTA Flash® Ro60 Calibrators | INOVA DIAGNOSTICS, INC. | |
| 11 | 08426950596653 | 701261 | 1. QUANTA Flash Ro52 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash Ro52 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro52 in stabilizers and preservatives. 2. QUANTA Flash Ro52 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro52 in stabilizers and preservatives. | QUANTA Flash® Ro52 Calibrators | INOVA DIAGNOSTICS, INC. | |
| 12 | 08426950596264 | 701151 | 1. QUANTA Flash SS-B Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash SS-B Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to SS-B in stabilizers and preservatives. 2. QUANTA Flash SS-B Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to SS-B in stabilizers and preservatives. | QUANTA Flash® SS-B Calibrators | INOVA DIAGNOSTICS, INC. | |
| 13 | 08426950596028 | 701121 | 1. QUANTA Flash Sm Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL 1. QUANTA Flash Sm Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Sm in stabilizers and preservatives. 2. QUANTA Flash Sm Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Sm in stabilizers and preservatives. | QUANTA Flash® Sm Calibrators | INOVA DIAGNOSTICS, INC. | |
| 14 | 08426950595724 | 701161 | 1. QUANTA Flash Jo-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash Jo-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Jo-1 in buffer, stabilizers, and preservatives.2. QUANTA Flash Jo-1 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL, prediluted, ready to use reagent. Calibrators contain human antibodies to Jo-1 in buffer, stabilizers, and preservatives. | QUANTA Flash® Jo-1 Calibrators | INOVA DIAGNOSTICS, INC. | |
| 15 | 08426950595717 | 701116 | 1. QUANTA Flash RNP Calibrator 1: Two (2) barcode labeled tubes containing 0.3 m 1. QUANTA Flash RNP Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to RNP in stabilizers and preservatives. 2. QUANTA Flash RNP Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to RNP in stabilizers and preservatives. | QUANTA Flash® RNP Calibrators | INOVA DIAGNOSTICS, INC. | |
| 16 | 08058056682291 | 04Y85-01 | 04Y85-01 | Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitr Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitro Diagnostic use. | Lipase NG OC Cal | SENTINEL CH. SPA |
| 17 | 08058056681768 | 1665001 | 1665001 | ACE Calibrator is intended to be used with Sentinel ACE Liquid Reagent for the p ACE Calibrator is intended to be used with Sentinel ACE Liquid Reagent for the preparation of the calibration for the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. For In Vitro Diagnostic use. | ACE Calibrator | SENTINEL CH. SPA |
| 18 | 07613336191552 | 09315314190 | 09315314190 | proBNP G2 CS Elecsys E2G V2.1 | Elecsys proBNP II CalSet | ROCHE DIAGNOSTICS GMBH |
| 19 | 07613336191545 | 09315306190 | 09315306190 | proBNP STAT CS Elecsys V2.1 | Elecsys proBNP II STAT CalSet | ROCHE DIAGNOSTICS GMBH |
| 20 | 07613336191538 | 09315292190 | 09315292190 | proBNP G2 CS Elecsys V2.1 | Elecsys proBNP II CalSet | ROCHE DIAGNOSTICS GMBH |
| 21 | 07613336172667 | 09038116190 | 09038116190 | Vitamin D total G3 CS Elecsys | CalSet Vitamin D total III | ROCHE DIAGNOSTICS GMBH |
| 22 | 07613336171776 | 09013326190 | 09013326190 | AMH CalSet | ROCHE DIAGNOSTICS GMBH | |
| 23 | 07613336170397 | 08932417190 | 08932417190 | FSH CalSet II | ROCHE DIAGNOSTICS GMBH | |
| 24 | 07613336169315 | 07679866190 | 07679866190 | CalSet Androstenedione | ROCHE DIAGNOSTICS GMBH | |
| 25 | 07613336160336 | 08496641190 | 08496641190 | CalSet Anti-TSHR | ROCHE DIAGNOSTICS GMBH | |
| 26 | 07613336157664 | 08443459160 | 08443459160 | TSH CalSet | ROCHE DIAGNOSTICS GMBH | |
| 27 | 07613336148280 | 08250499160 | 08250499160 | CalSet Troponin T Gen 5 | ROCHE DIAGNOSTICS GMBH | |
| 28 | 07613336147696 | 08243930190 | 08243930190 | CalSet PTH STAT | ROCHE DIAGNOSTICS GMBH | |
| 29 | 07613336147689 | 08243891190 | 08243891190 | CalSet II PTH | ROCHE DIAGNOSTICS GMBH | |
| 30 | 07613336147672 | 08243875190 | 08243875190 | CalSet PTH | ROCHE DIAGNOSTICS GMBH | |
| 31 | 07613336143148 | 07475969190 | 07475969190 | CalSet IGF-1 | ROCHE DIAGNOSTICS GMBH | |
| 32 | 07613336142707 | 07574762190 | 07574762190 | CalSet IGFBP-3 | ROCHE DIAGNOSTICS GMBH | |
| 33 | 06944904084985 | 105-011385-00 | Urine Standard (Indirect)(FDA) | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
| 34 | 06944904084978 | 105-011384-00 | Serum Standard (Indirect)(FDA) | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
| 35 | 05700572014294 | X0974 | Cystatin C Calibrator | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 36 | 05700572014287 | X0973 | Cystatin C Control Set | Cystatin C Control Set | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 37 | 05700572013853 | LX002 | Cystatin C Immunoparticles | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 38 | 05391516741866 | 450-11 | 450-11 | Bile Acid Calibrator Set (5 x 5 mL) | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
| 39 | 05391516741859 | 450-100 | 450-100 | Bile Acid Calibrator 100 umol/l (5 mL) | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
| 40 | 05055845400282 | FHBC100/B08176 | FHBC100/B08176 | The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quan The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent | AXIS-SHIELD DIAGNOSTICS LIMITED |
| 41 | 05055845400169 | FHRWR100 | FHRWR100 | The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quan The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit | AXIS-SHIELD DIAGNOSTICS LIMITED |
| 42 | 05055273216882 | CYS10445 | CYS10445 | Intended for in vitro diagnostic (IVD) use in the calibration of Randox Cystatin Intended for in vitro diagnostic (IVD) use in the calibration of Randox Cystatin C assay. For use in a clinical laboratory setting by trained personnel. | CYSTATIN C CALIBRATOR (CYSC CAL) | RANDOX LABORATORIES LIMITED |
| 43 | 05055273215557 | TF10161 | TF10161 | The Randox Soluble Transferrin Receptors Calibrator Series is intended for use i The Randox Soluble Transferrin Receptors Calibrator Series is intended for use in the calibration of Soluble Transferrin Receptors assays. | SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES (STFR CAL) | RANDOX LABORATORIES LIMITED |
| 44 | 05055273215540 | HA8124 | HA8124 | The HbA1c II Calibrator is intended for use in the calibration of the HbA1c II assay. | HbA1c II CALIBRATOR SET (HbA1c II CAL) | RANDOX LABORATORIES LIMITED |
| 45 | 05055273214550 | SC10154 | SC10154 | This product is intended for in vitro diagnostic use, in the calibration of the This product is intended for in vitro diagnostic use, in the calibration of the Randox Ransel assay. | RANSEL CALIBRATOR (RANSEL CAL) | RANDOX LABORATORIES LIMITED |
| 46 | 05055273213904 | AO2800 | ADIPONECTIN CALIBRATOR (ADPN CAL) | RANDOX LABORATORIES LIMITED | ||
| 47 | 05055273209204 | LP5047 | APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2) | RANDOX LABORATORIES LIMITED | ||
| 48 | 05055273208733 | FR4030 | FR4030 | FRUCTOSAMINE (FRUC) | RANDOX LABORATORIES LIMITED | |
| 49 | 05055273208436 | CH5050 | sLDL CALIBRATOR (sLDL CAL) | RANDOX LABORATORIES LIMITED | ||
| 50 | 05055273208405 | CG5037 | COAGULATION CALIBRATOR (COAG CAL) | RANDOX LABORATORIES LIMITED |