No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00380740193867 | 06S6130 | 06S6130 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 1000 Test | QKO | Reagent, coronavirus serological | Alinity | |
2 | 00380740193843 | 06S6120 | 06S6120 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 200 Test | QKO | Reagent, coronavirus serological | Alinity | |
3 | 00380740193829 | 06S6110 | 06S6110 | AdviseDx SARS-CoV-2 IgG II Control Kit | QKO | Reagent, coronavirus serological | Alinity | |
4 | 00380740193805 | 06S6101 | 06S6101 | AdviseDx SARS-CoV-2 IgG II Calibrator Kit | QKO | Reagent, coronavirus serological | Alinity | |
5 | 00380740193782 | 06S6030 | 06S6030 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test | QKO | Reagent, coronavirus serological | ARCHITECT | |
6 | 00380740193768 | 06S6020 | 06S6020 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test | QKO | Reagent, coronavirus serological | ARCHITECT | |
7 | 00380740193744 | 06S6010 | 06S6010 | AdviseDx SARS-CoV-2 IgG II Control Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
8 | 00380740112424 | 07K68-35 | 07K6835 | ARCHITECT CEA Reagent kit | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
9 | 00380740112400 | 3P36-35 | 03P3635 | ARCHITECT AFP Reagent Kit | LOK | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | 3 | ARCHITECT |
10 | 00380740105433 | 1L82-36 | 01L8236 | ARCHITECT AUSAB Reagent | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | ARCHITECT |
11 | 00380740105426 | 1L82-26 | 01L8226 | ARCHITECT AUSAB Reagent | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | ARCHITECT |
12 | 00380740105419 | 1L82-13 | 01L8213 | ARCHITECT AUSAB Controls | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | ARCHITECT |
13 | 00380740105402 | 1L82-03 | 01L8203 | ARCHITECT AUSAB Calibrators | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | ARCHITECT |
14 | 00380740081317 | 3P36-25 | 03P3625 | ARCHITECT AFP Reagent Kit | LOK | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | 3 | ARCHITECT |
15 | 00380740081294 | 3P36-10 | 03P3610 | ARCHITECT AFP Controls | LOK | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | 3 | ARCHITECT |
16 | 00380740081287 | 3P36-01 | 03P3601 | ARCHITECT AFP Calibrators | LOK | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | 3 | ARCHITECT |
17 | 00380740014582 | 07K68-32 | 07K6832 | ARCHITECT CEA Reagent kit | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
18 | 00380740014575 | 07K68-27 | 07K6827 | ARCHTECT CEA Reagent kit | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
19 | 00380740014551 | 07K68-12 | 07K6812 | ARCHITECT CEA Controls | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
20 | 00380740014544 | 07K68-02 | 07K6802 | ARCHITECT CEA Calibrators | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
21 | 00380740013066 | 7D82-50 | 07D8250 | ARCHITECT Multi -Assay Manual Diluent | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
22 | 00380740009786 | 06E2365 | 06E2365 | ARCHITECT PRE TRIGGER SOLUTION | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
23 | 00380740009625 | 6C55-60 | 06C5560 | ARCHITECT TRIGGER SOLUTION | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
24 | 00380740009618 | 6C54-88 | 06C5488 | ARCHITECT CONCENTRATED WASH BUFFER (10L) | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
25 | 00380740009601 | 6C54-58 | 06C5458 | ARCHITECT CONCENTRATED WASH BUFFER | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
26 | 00380740009021 | 6C07-27 | 06C0727 | ARCHITECT Free PSA Reagent Kit | MTG | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCE TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS | 3 | ARCHITECT |
27 | 00380740009014 | 6C07-10 | 06C0710 | ARCHITECT Free PSA Controls | MTG | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCE TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS | 3 | ARCHITECT |
28 | 00380740009007 | 6C07-01 | 06C0701 | ARCHITECT Free PSA Calibrators | MTG | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCE TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS | 3 | ARCHITECT |
29 | 00380740008994 | 6C06-35 | 06C0635 | ARCHITECT Total PSA Reagent Kit | JJX,JJE,JIS,LTJ,MTF | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED),ANALYZER, CHEMISTRY SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED),ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE,CALIBRATOR, PRIMARY,PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS,TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER | 1 | ARCHITECT |
30 | 00380740008987 | 6C06-27 | 06C0627 | ARCHITECT Total PSA Reagent Kit | LTJ,JJX,JIS,JJE,MTF | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS,SINGLE (SPECI PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS,SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED),CALIBRATOR, PRIMARY,ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE,TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER | 1 | ARCHITECT |
31 | 00380740193720 | 06S6001 | 06S6001 | AdviseDx SARS-CoV-2 IgG II Calibrator Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
32 | 00380740192167 | 06R8730 | 06R8730 | AdviseDx SARS-CoV-2 IgM Reagent Kit 500 Test | QKO | Reagent, coronavirus serological | ARCHITECT | |
33 | 00380740192099 | 06R9130 | 06R9130 | AdviseDx SARS-CoV-2 IgM Reagent Kit 1000 Test | QKO | Reagent, coronavirus serological | Alinity | |
34 | 00380740192082 | 06R9120 | 06R9120 | AdviseDx SARS-CoV-2 IgM Reagent Kit 200 Test | QKO | Reagent, coronavirus serological | Alinity | |
35 | 00380740192075 | 06R9110 | 06R9110 | AdviseDx SARS-CoV-2 IgM Control Kit | QKO | Reagent, coronavirus serological | Alinity | |
36 | 00380740192068 | 06R9101 | 06R9101 | AdviseDx SARS-CoV-2 IgM Calibrator Kit | QKO | Reagent, coronavirus serological | Alinity | |
37 | 00380740191863 | 06R8720 | 06R8720 | AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test | QKO | Reagent, coronavirus serological | ARCHITECT | |
38 | 00380740191856 | 06R8710 | 06R8710 | AdviseDx SARS-CoV-2 IgM Control Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
39 | 00380740191849 | 06R8701 | 06R8701 | AdviseDx SARS-CoV-2 IgM Calibrator Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
40 | 00380740174941 | 04V3831 | 04V3831 | Alinity i STAT CK-MB Reagent Kit 1000 Tests | JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | Alinity |
41 | 00380740174927 | 04V3821 | 04V3821 | Alinity i STAT CK-MB Reagent Kit 200 Tests | JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | Alinity |
42 | 00380740174910 | 04V3730 | 04V3730 | Alinity i STAT Myoglobin Reagent Kit 1000 Tests | DDR | MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Alinity |
43 | 00380740174903 | 04V3720 | 04V3720 | Alinity i STAT Myoglobin Reagent Kit 200 Tests | DDR | MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Alinity |
44 | 00380740172282 | 04V3710 | 04V3710 | Alinity i STAT Myoglobin Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Alinity |
45 | 00380740172275 | 04V3701 | 04V3701 | Alinity i STAT Myoglobin Calibrators | JIS | Calibrator, primary | 2 | Alinity |
46 | 00380740165482 | 04V3801 | 04V3801 | Alinity i STAT CK-MB Calibrators | JIS | Calibrator, primary | 2 | Alinity |
47 | 00380740158347 | 07P9331 | 07P9331 | Alinity i Free PSA Reagent Kit 1000 Tests | MTG | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate ca Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions | 3 | Alinity |
48 | 00380740158330 | 07P9321 | 07P9321 | Alinity i Free PSA Reagent Kit 200 Tests | MTG | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate ca Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions | 3 | Alinity |
49 | 00380740158323 | 07P9231 | 07P9231 | Alinity i Total PSA Reagent Kit 1200 Tests | MTF | Total, prostate specific antigen (noncomplexed & complexed) for detection of pro Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer | 3 | Alinity |
50 | 00380740158316 | 07P9221 | 07P9221 | Alinity i Total PSA Reagent Kit 200 Tests | MTF | Total, prostate specific antigen (noncomplexed & complexed) for detection of pro Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer | 3 | Alinity |
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 |