| 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 | 00812137012197 | L1 x 3mL, L2 x 3mL, L3 x 3mL | 502-160 | This product is intended for in-vitro use in the quality control of HDL, LDL, Ap This product is intended for in-vitro use in the quality control of HDL, LDL, Apolipoprotein A-1, Apolipoprotein B, and Lipopro-tein (a) methods on clinical chemistry systems. The Multi-Analyte Lipid Control Set is a set of three serum levels. These three levels are to be used exclusively with the CDS HDL Cholesterol Reagent, CDS LDL Cholesterol Reagent, (CDS 501-419 and CDS 501-420) which are assays for the quan-tification of various lipids and lipoproteins in human serum. | Multi-Analyte Lipid Control Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
| 2 | 00812137012135 | 10 x 5mL | 502-153 | The Chemistry Control Level II is to be used for monitoring the accuracy and pre The Chemistry Control Level II is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. For in vitro diagnostic use only. The quality control material is prepared from human serum with enzymes, nonprotein constituents, non-human protein, and bacteriostatic agents added. The constituents were adjusted to the levels listed in Expected Values. | Chemistry Control Level II Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
| 3 | 00812137012128 | 10 x 5mL | 502-152 | The Chemistry Control Level I is to be used for monitoring the accuracy and prec The Chemistry Control Level I is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. For in vitro diagnostic use only. The quality control material is prepared from human serum with enzymes, nonprotein constituents, non-human protein, and bacteriostatic agents added. | Chemistry Control Level I Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
| 4 | 00811727014153 | 13-C7591-CTL-5 | 13-C7591-CTL-5 | For in vitro diagnostic use only. The Chemistry Control is to be used for monito For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. The assayed multi-analyte control product is packaged with one level of analytes.1x 5 ml | Pointe Scientific, Inc. Chem Ctl Level 2 | POINTE SCIENTIFIC, INC. |
| 5 | 00811727014146 | 13-C7590-CTL-5 | 13-C7590-CTL-5 | For in vitro diagnostic use only. The Chemistry Control is to be used for monito For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. The assayed multi-analyte control product is packaged with one level of analytes.1x 5 ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 6 | 00811727011848 | L7580-18 | L7580-18 | Pointe Scientific, Inc. Lipid Control Set are assayed Lipid Controls produced fr Pointe Scientific, Inc. Lipid Control Set are assayed Lipid Controls produced from fresh human sera to monitor the accuracy and precision of quantitative lipid determinations of human sera specimens.6 x 3 ml. | Pointe Scientfic, Inc. Lipid Controls | POINTE SCIENTIFIC, INC. |
| 7 | 00811727010971 | C7562-12 | C7562-12 | This CK-MB Isoenzyme Control has been assayed for CK-MB and is intended to be us This CK-MB Isoenzyme Control has been assayed for CK-MB and is intended to be used as a human serum control product for CK-MB determinations. | POINTE SCIENTIFIC CK-MB Controls | POINTE SCIENTIFIC, INC. |
| 8 | 00811727010735 | C7592-100 | C7592-100 | For in vitro diagnostic use only. The Chemistry Control is to be used for monito For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. The assayed multi-analyte control product is packaged with one level of analytes. | POINTE SCIENTIFIC Chemistry Control, Level 1 & 2 | POINTE SCIENTIFIC, INC. |
| 9 | 00811727010728 | C7591-50 | C7591-50 | For in vitro diagnostic use only. The Chemistry Control is to be used for monito For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. The assayed multi-analyte control product is packaged with one level of analytes. | POINTE SCIENTIFIC Chemistry Control, Level 2 | POINTE SCIENTIFIC, INC. |
| 10 | 00811727010711 | C7590-50 | C7590-50 | For in vitro diagnostic use only. The Chemistry Control is to be used for monito For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. The assayed multi-analyte control product is packaged with one level of analytes. | POINTE SCIENTIFIC Chemistry Control, Level 1 | POINTE SCIENTIFIC, INC. |
| 11 | 00811727010070 | A7504-CTL | A7504-CTL | "For in vitro diagnostic use only.The Pointe Scientific, Inc. Ammonia / Alcohol "For in vitro diagnostic use only.The Pointe Scientific, Inc. Ammonia / Alcohol Control set is to be used for monitoring the accuracy and precision of various ammonia and / or ethanol assay methods and to validate quantitation of patient samples. The controls contain components of known concentrations and are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method. (475 characters)" | POINTE SCIENTIFIC Ammonia/Alcohol Controls | POINTE SCIENTIFIC, INC. |
| 12 | 00695684710033 | 71003 | Tri-level, For use with qualitative hCG serum tests. | HCG SERUM CONTROLS | GERMAINE LABORATORIES, INC | |
| 13 | 00695684710026 | 71002 | Bi-level, For use with qualitative hCG urine tests. | HCG URINE CONTROLS | GERMAINE LABORATORIES, INC | |
| 14 | 00657498002377 | 3063-006 | 3063-006 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - High | STANBIO LABORATORY, L.P. |
| 15 | 00657498002360 | 3063-003 | 3063-003 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - High | STANBIO LABORATORY, L.P. |
| 16 | 00657498002353 | 3062-006 | 3062-006 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - Normal | STANBIO LABORATORY, L.P. |
| 17 | 00657498002346 | 3062-003 | 3062-003 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - Normal | STANBIO LABORATORY, L.P. |
| 18 | 00657498002339 | 3061-006 | 3061-006 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - Low | STANBIO LABORATORY, L.P. |
| 19 | 00657498002322 | 3061-003 | 3061-003 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - Low | STANBIO LABORATORY, L.P. |
| 20 | 00657498002032 | 3060-101H | 3060-101H | A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system. | Hgb Control, High | STANBIO LABORATORY, L.P. |
| 21 | 00657498002025 | 3060-101N | 3060-101N | A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system. | Hgb Control, Normal | STANBIO LABORATORY, L.P. |
| 22 | 00657498002018 | 3060-101L | 3060-101L | A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system. | Hgb Control, Low | STANBIO LABORATORY, L.P. |
| 23 | 00657498001431 | 3065-201 | 3065-201 | A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin t A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin testing system. | Bi-Level Hgb Controls | STANBIO LABORATORY, L.P. |
| 24 | 00657498001219 | G428-86 | G428-86 | Use as a control serum to monitor the accuracy and precision of manual and autom Use as a control serum to monitor the accuracy and precision of manual and automated methods used in clinical chemistry. | Ser-T-Fy 2, Level 2 Control | STANBIO LABORATORY, L.P. |
| 25 | 00657498001202 | G427-86 | G427-86 | Use as a control serum to monitor the accuracy and precision of manual and autom Use as a control serum to monitor the accuracy and precision of manual and automated methods used in clinical chemistry. | Ser-T-Fy 1, Level 1 Control | STANBIO LABORATORY, L.P. |
| 26 | 00657498001189 | 1235-305 | 1235-305 | For Use as hCG Pregnancy Controls in Qualitative Serum hCG Pregnancy Procedures. | hCG Tri-Level Serum Controls | STANBIO LABORATORY, L.P. |
| 27 | 00657498001172 | 1225-205 | 1225-205 | For Use as hCG Pregnancy Controls in Qualitative Urine hCG Pregnancy Procedures. | hCG Bi-Level Urine Controls | STANBIO LABORATORY, L.P. |
| 28 | 00657498000243 | 3065-601 | 3065-601 | A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin t A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin testing system. | Bi-Level Hgb Controls | STANBIO LABORATORY, L.P. |
| 29 | 00630414284996 | 10873685 | OQDC17 | Assayed control for RF, ASL and CRP assays on BN Systems | N/T Rheumatology Control SL/2 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 30 | 00630414284989 | 10873684 | OQDB17 | Assayed control for RF, ASL and CRP assays on BN Systems | N/T Rheumatology Control SL/1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 31 | 00630414237503 | 10873663 | OPJF05 | Assayed accuracy and precision controls in the determination of free light chain Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN Systems. | N FLC CONTROL SL2 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 32 | 00630414237480 | 10873661 | OPJE05 | Assayed accuracy and precision controls in the determination of free light chain Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN Systems. | N FLC CONTROL SL1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 33 | 00630414202174 | 10309926 | 108868 | For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE A For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE Analyzers, CO-oximeters and Metabolite Analyzers. | RAPIDQC® Complete Level 2 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 34 | 00630414202167 | 10309927 | 108869 | For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE A For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE Analyzers, CO-oximeters and Metabolite Analyzers. | RAPIDQC® Complete Level 3 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 35 | 00630414202150 | 10309925 | 108860 | For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE A For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE Analyzers, CO-oximeters and Metabolite Analyzers. | RAPIDQC® Complete Level 1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 36 | 00630414195131 | 10316535 | 116189 | Calibration Verification Material (CVM®) to verify the calibration of blood gas, Calibration Verification Material (CVM®) to verify the calibration of blood gas, electrolytes, total hemoglobin (tHb) and metabolite systems. | CVM® Calibration Verification Material | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 37 | 00630414121802 | 10330034 | 570407 | Calibration Verification Material for Hematocrit (CVM® Hct) is a unique material Calibration Verification Material for Hematocrit (CVM® Hct) is a unique material formulated to verify the calibration of conductivity-based hematocrit test systems. | CVM® Hct Calibration Verification Material for Hematocrit Systems | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 38 | 00630414121628 | 10311387 | 570097 | For in vitro diagnostic use for verifying glucose and lactate sensor performance For in vitro diagnostic use for verifying glucose and lactate sensor performance on the RAPIDLab® 1260 & 1265 systems | RAPIDLab® High G/L | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 39 | 00630414112985 | 10340375 | 477440000 | The blood gas Proficiency Pre-Test is a pre-proficiency test material supplied t The blood gas Proficiency Pre-Test is a pre-proficiency test material supplied three times a year for verifying performance of pH/blood gas, electrolyte, metabolite and CO-oximetry analyzers. | Proficiency Pre-Test | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 40 | 00628063401222 | SM-057 | DC-TROL LEVELS 1 & 2 | SEKISUI DIAGNOSTICS, LLC | ||
| 41 | 00628063400461 | SM-056 | SM-056 | DC-TROL Level 2 | SEKISUI DIAGNOSTICS, LLC | |
| 42 | 00628063400454 | SM-052 | SM-052 | DC-TROL Level 1 | SEKISUI DIAGNOSTICS, LLC | |
| 43 | 00386100004385 | 10340 | 10340 | EasyRA Analyzer - ISE & LIS | EasyRA Analyzer (ISE&LIS) | MEDICA CORPORATION |
| 44 | 00386100004378 | 10360 | 10360 | EasyRA Analyzer - LIS | EasyRA Analyzer (LIS) | MEDICA CORPORATION |
| 45 | 00386100002282 | 5423-0041 | 5423-0041 | ISE Reagent Pack for use with EasyRA Analyzers | ISE Reagent Pack | MEDICA CORPORATION |
| 46 | 00386100002206 | 10224-4 | 10224-4 | LDL Cholesterol Reagent Kit for use with EasyRA Analyzers | LDL CHOL Reagent Kit | MEDICA CORPORATION |
| 47 | 00386100001889 | 10794 | 10794 | EasyQC Quality Control Kit - Level B for use with EasyRA Analyzer | QC Kit, Level B | MEDICA CORPORATION |
| 48 | 00386100001872 | 10793 | 10793 | EasyQC Quality Control Kit - Level for use with EasyRA Analyzer | QC Kit, Level A | MEDICA CORPORATION |
| 49 | 00385480561983 | PHOX | 56198 | Linearity Standard Set G Multipack | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
| 50 | 00385480534567 | PRIME ABG | 53456 | Prime Auto QC Cartridge ABG 100 Sample | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |