| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 30014613338123 | 94614 | 94614 | Triage TOX Drug Screen, 94600 Control 2 | DIF | Drug mixture control materials | 1 | Triage |
| 2 | 30014613338116 | 94613 | 94613 | Triage TOX Drug Screen, 94600 Control 1 | DIF | Drug mixture control materials | 1 | Triage |
| 3 | 30014613338109 | 94600 | 94600 | Triage TOX Drug Screen, 94600 | LAF,KHO,DIS,JXM,LFG,LDJ,JXO,DJR,DJG | Gas chromatography, methamphetamine,FLUOROMETER, FOR CLINICAL USE,Enzyme immunoa Gas chromatography, methamphetamine,FLUOROMETER, FOR CLINICAL USE,Enzyme immunoassay, barbiturate,Enzyme immunoassay, benzodiazepine,Radioimmunoassay, tricyclic antidepressant drugs,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, cocaine,Enzyme immunoassay, methadone,Enzyme immunoassay, opiates | 1 | Triage |
| 4 | 30014613338048 | 98800EU | 98800EU | Triage PLGF Test (OUS) | PZN | Placental growth factor test | Triage | |
| 5 | 30014613338031 | 98700EU | 98700EU | Triage NT-proBNP Test (OUS) | NBC | TEST,NATRIURETIC PEPTIDE | 2 | Triage |
| 6 | 30014613338024 | 98600EU | 98600EU | Triage Troponin I Test (OUS) | MMI | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | Triage |
| 7 | 30014613338017 | 98100EU | 98100EU | Triage D-Dimer Test (OUS) | DAP | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | 2 | Triage |
| 8 | 30014613338000 | 98100 | 98100 | Triage D-Dimer Test | DAP | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | 2 | Triage |
| 9 | 30014613337997 | 98000XREU | 98000XREU | Triage BNP Test (OUS) | NBC | TEST,NATRIURETIC PEPTIDE | 2 | Triage |
| 10 | 30014613337980 | 98000XR | 98000XR | Triage BNP Test | NBC | TEST,NATRIURETIC PEPTIDE | 2 | Triage |
| 11 | 30014613337973 | 97500EU | 97500EU | Triage Cardio2 Panel | NBC,MMI | TEST,NATRIURETIC PEPTIDE,IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | Triage |
| 12 | 30014613337966 | 97400EU | 97400EU | Triage Cardio3 Panel | MMI,JHX,NBC | IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,TEST IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,TEST,NATRIURETIC PEPTIDE | 2 | Triage |
| 13 | 30014613337959 | 97300EU | 97300EU | Triage Profiler SOB Panel (OUS) | DDR,MMI,JHX,NBC,DAP | MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL,IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUO MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL,IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,TEST,NATRIURETIC PEPTIDE,FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | 2 | Triage |
| 14 | 30014613337942 | 97022HS | 97022HS | Triage Cardiac Panel (CK/TnI) | MMI,JHX | IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | Triage |
| 15 | 30014613337935 | 97021HS | 97021HS | Triage Cardiac Panel (TnI) | MMI | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | Triage |
| 16 | 30014613337928 | 97000HSEU | 97000HSEU | Triage Cardiac Panel (OUS) | DOR,MMI,JHX | RADIOIMMUNOASSAY, DIGOXIN (3-H), BOVINE ANTIBODY, CHARCOAL SEP.,IMMUNOASSAY METH RADIOIMMUNOASSAY, DIGOXIN (3-H), BOVINE ANTIBODY, CHARCOAL SEP.,IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | Triage |
| 17 | 30014613337911 | 97000HS | 97000HS | Triage Cardiac Panel | MMI,JHX,DDR | IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,MYOG IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Triage |
| 18 | 30014613337904 | 94400EU | 94400EU | Triage TOX Drug Screen (OUS) | LAF,LDP,DKZ,DJG,LCM,LDJ,DIS,JXO,MLK,JXM,DJR | Gas chromatography, methamphetamine,COLORIMETRY, ACETAMINOPHEN,Enzyme immunoassa Gas chromatography, methamphetamine,COLORIMETRY, ACETAMINOPHEN,Enzyme immunoassay, amphetamine,Enzyme immunoassay, opiates,Enzyme immunoassay, phencyclidine,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, barbiturate,Enzyme immunoassay, cocaine,Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, benzodiazepine,Enzyme immunoassay, methadone | 2 | Triage |
| 19 | 30014613337898 | 94404 | 94404 | Triage TOX Drug Screen (7 Panel) | LAF,DKZ,DJG,DIS,JXO,JXM,LDJ | Gas chromatography, methamphetamine,Enzyme immunoassay, amphetamine,Enzyme immun Gas chromatography, methamphetamine,Enzyme immunoassay, amphetamine,Enzyme immunoassay, opiates,Enzyme immunoassay, barbiturate,Enzyme immunoassay, cocaine,Enzyme immunoassay, benzodiazepine,Enzyme immunoassay, cannabinoids | 2 | Triage |
| 20 | 30014613337881 | 94402 | 94402 | Triage TOX Drug Screen (9 Panel) | DKZ,DJG,LAF,LCM,MLK,JXO,LDJ,DIS,JXM | Enzyme immunoassay, amphetamine,Enzyme immunoassay, opiates,Gas chromatography, Enzyme immunoassay, amphetamine,Enzyme immunoassay, opiates,Gas chromatography, methamphetamine,Enzyme immunoassay, phencyclidine,Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, cocaine,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, barbiturate,Enzyme immunoassay, benzodiazepine | 2 | Triage |
| 21 | 30014613337874 | 94401 | 94401 | Triage TOX Drug Screen (10 Panel) | MLK,LCM,DKZ,DJR,LAF,DIS,LDJ,JXM,DJG,JXO | Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, p Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, phencyclidine,Enzyme immunoassay, amphetamine,Enzyme immunoassay, methadone,Gas chromatography, methamphetamine,Enzyme immunoassay, barbiturate,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, benzodiazepine,Enzyme immunoassay, opiates,Enzyme immunoassay, cocaine | 2 | Triage |
| 22 | 30014613337867 | 94400 | 94400 | Triage TOX Drug Screen | LDP,MLK,DKZ,LAF,JXM,LCM,LDJ,DIS,JXO,DJR,DJG | COLORIMETRY, ACETAMINOPHEN,Thin layer chroomatography, tricyclic antidepressant COLORIMETRY, ACETAMINOPHEN,Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, amphetamine,Gas chromatography, methamphetamine,Enzyme immunoassay, benzodiazepine,Enzyme immunoassay, phencyclidine,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, barbiturate,Enzyme immunoassay, cocaine,Enzyme immunoassay, methadone,Enzyme immunoassay, opiates | 2 | Triage |
| 23 | 30014613337720 | 98202 | 98202 | Triage BNP Calibrators | JIT | Calibrator, secondary | 2 | Triage |
| 24 | 30014613337713 | 98201 | 98201 | Triage BNP QC Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 25 | 30014613337706 | 98200 | 98200 | Triage BNP Reagents | NBC | TEST,NATRIURETIC PEPTIDE | 2 | Triage |
| 26 | 30014613337164 | 55071 | 55071 | Triage MeterPro, International | JHX,KHO,MMI,DDR | FLUOROMETRIC METHOD, CPK OR ISOENZYMES,FLUOROMETER, FOR CLINICAL USE,IMMUNOASSAY FLUOROMETRIC METHOD, CPK OR ISOENZYMES,FLUOROMETER, FOR CLINICAL USE,IMMUNOASSAY METHOD, TROPONIN SUBUNIT,MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | 1 | Triage |
| 27 | 30014613337157 | 55070 | 55070 | Triage MeterPro, North America | MMI,JHX,DDR,KHO | IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,MYOG IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL,FLUOROMETER, FOR CLINICAL USE | 1 | Triage |
| 28 | 30014613337140 | 94414 | 94414 | Quidel Triage TOX Drug Screen Control 2 | DIF | Drug mixture control materials | 1 | Triage |
| 29 | 30014613337133 | 94413 | 94413 | Quidel Triage TOX Drug Screen Control 1 | DIF | Drug mixture control materials | 1 | Triage |
| 30 | 30014613337126 | 88755 | 88755 | Quidel Triage Total 5 Calibration Verification | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Triage |
| 31 | 30014613337119 | 88754 | 88754 | Quidel Triage Total 5 Control 2 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Triage |
| 32 | 30014613337102 | 88753 | 88753 | Quidel Triage Total 5 Control 1 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Triage |
| 33 | 30014613337096 | 88734 | 88734 | Quidel Triage Total 3 Control 2 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Triage |
| 34 | 30014613337072 | 98814EU | 98814EU | Triage PLGF Control 2 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 35 | 30014613337065 | 98813EU | 98813EU | Triage PLGF Control 1 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 36 | 30014613337058 | 98714EU | 98714EU | Triage NT-proBNP Control 2 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 37 | 30014613337041 | 98713EU | 98713EU | Triage NT-proBNP Control 1 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 38 | 30014613337034 | 98015XR | 98015XR | Quidel Triage® BNP Calibration Verification | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 39 | 30014613337027 | 98014XR | 98014XR | Quidel Triage® BNP Control 2 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 40 | 30014613337010 | 98013XR | 98013XR | Triage BNP Control 1 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 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 |