| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00875197005936 | 07972466190 | 07972466190 | cobas Zika (480 tests) | ||||
| 2 | 00365702398108 | 5530199160 | 5530199160 | GJS | TEST, TIME, PROTHROMBIN | 2 | CoaguChek XS Pro Kit | |
| 3 | 00075537180075 | 11379194160 | 11379194160 | KHE | REAGENT, OCCULT BLOOD | 2 | Calibration Strip (Urisys 1100, cobas u 411) | |
| 4 | 00075537018934 | 11893467160 | 11893467160 | CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) | 1 | Chemstrip 5 OB Test Strips | |
| 5 | 07613336215845 | 08836973160 | 08836973160 | Elecsys HIV Duo | MZF | Test, HIV detection | 2 | Elecsys HIV Duo |
| 6 | 07613336184615 | 09038078160 | 09038078160 | Vitamin D total G3 Elecsys cobas e 100 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
| 7 | 07613336179512 | 09205683001 | 09205683001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro transport line | |
| 8 | 07613336179499 | 09205632001 | 09205632001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro SSU | |
| 9 | 07613336172650 | 09038086190 | 09038086190 | Vitamin D total G3 Elecsys E2G 300 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
| 10 | 07613336171677 | 09007784190 | 09007784190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
| 11 | 07613336171660 | 09007741190 | 09007741190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
| 12 | 07613336170212 | 08924180160 | 08924180160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
| 13 | 07613336170182 | 08924163160 | 08924163160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
| 14 | 07613336166949 | 08836973190 | 08836973190 | MZF | Test, HIV detection | 2 | Elecsys HIV Duo | |
| 15 | 07613336164884 | 08764760190 | 08764760190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
| 16 | 07613336159804 | 04985354160 | 04985354160 | Anti-HBs CC 3 Elecsys | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | Anti-HBs CalCheck |
| 17 | 07613336158784 | 08463662001 | 08463662001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas c 503 analytical unit | |
| 18 | 07613336155332 | 08372284001 | 08372284001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
| 19 | 07613336155318 | 08376824190 | 08376824190 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
| 20 | 07613336154403 | 03500373190 | 03500373190 | 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 | free PSA CalCheck | |
| 21 | 07613336154373 | 04491734160 | 04491734160 | tPSA reagent 200 | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
| 22 | 07613336154366 | 04641655160 | 04641655160 | tPSA reagent, 100 Test-Kit | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
| 23 | 07613336154311 | 06427405160 | 06427405160 | Anti-HCV II 200-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
| 24 | 07613336154304 | 06368921160 | 06368921160 | Anti-HCV II 100-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
| 25 | 07613336153949 | 04927931161 | 04927931161 | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | PreciControl Anti-HBc II | |
| 26 | 07613336147672 | 08243875190 | 08243875190 | JIT | Calibrator, secondary | 2 | CalSet PTH | |
| 27 | 07613336141953 | 5920353001 | 5984840001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
| 28 | 07613336133644 | 08105596190 | 08105596190 | NDY | TEST, CYSTATIN C | 2 | Tina-quant Cystatin C Gen.2 | |
| 29 | 07613336133583 | 08105529190 | 08105529190 | JZG | System, test, beta-2-microglobulin immunological | 2 | Tinaquant ß2Microglobulin | |
| 30 | 07613336133521 | 08105448190 | 08105448190 | DER | ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Apolipoprotein A-1 ver.2 | |
| 31 | 07613336130230 | 08101396190 | 08101396190 | DEM | ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant a1-Antitrypsin ver.2 | |
| 32 | 07613336121429 | 08058024190 | 08058024190 | JIF | ENZYMATIC METHOD, AMMONIA | 1 | Ammonia II | |
| 33 | 07613336121351 | 08057940190 | 08057940190 | KHP | ACID, LACTIC, ENZYMATIC METHOD | 1 | Lactate Gen.2 | |
| 34 | 07613336121238 | 08057648190 | 08057648190 | DBF | FERRITIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Ferritin Gen.4 | |
| 35 | 07613336121108 | 08057435190 | 08057435190 | KLT | ENZYME IMMUNOASSAY, CARBAMAZEPINE | 2 | ONLINE TDM Carbamazepine Gen.4 | |
| 36 | 07613336121061 | 08056951190 | 08056951190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Bilirubin Direct Gen.2 | |
| 37 | 04015630999477 | 5133181160 | 5133181160 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Elecsys Anti-CCP CalCheck | |
| 38 | 04015630995318 | 11776827160 | 11776827160 | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | Elecsys CalCheck FSH | |
| 39 | 04015630999200 | 4357221190 | 4357221190 | DLJ | CALIBRATORS, DRUG SPECIFIC | 2 | Total MPA Calibrators | |
| 40 | 04015630999149 | 4924495190 | 4924495190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
| 41 | 04015630997954 | 4642465190 | 4642465190 | LEG | ENZYME IMMUNOASSAY, VALPROIC ACID | 2 | Valproic Acid ONLINE TDM Valproic Acid | |
| 42 | 04015630997756 | 4490894190 | 4490894190 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
| 43 | 04015630996575 | 3304680190 | 3304680190 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | Preciset DAT Plus II | |
| 44 | 04015630995202 | 11776614190 | 11776614190 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | AFP CalCheck | |
| 45 | 04015630994847 | 11815601216 | 11815601216 | LGI | FLUORESCENCE POLARIZATION IMMUNOASSAY, CARBAMAZEPINE | 2 | CEDIA Carbamazepine II | |
| 46 | 04015630994533 | 20766356122 | 20766356122 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | LSD CalibrationControl Pack | |
| 47 | 04015630993468 | 20737976122 | 20737976122 | DIS | ENZYME IMMUNOASSAY, BARBITURATE | 2 | Abuscreen OnLine Barbiturates | |
| 48 | 04015630993284 | 11986082216 | 11986082216 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
| 49 | 04015630991853 | 11876899216 | 11876899216 | CFR | HEXOKINASE, GLUCOSE | 2 | Glucoquant GlucoseHK | |
| 50 | 04015630991778 | 11868152190 | 11868152190 | DML | NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD | 2 | Ethyl Alcohol ETH |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00630414976624 | 10463371 | RF642 | LOCI Vitamin B12 Flex® reagent cartridge, 80 tests | Dimension® EXL™ VB12 Flex® reagent cartridge | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 2 | 00630414964874 | 10380900 | LKVB1 | Vitamin B12 - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems VB Vitamin B12 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 3 | 00630414954448 | 10386999 | LVBZ | Vitamin B12 Sample Diluent - IMMULITE - 1x25mL | IMMULITE®/IMMULITE® 1000 Systems VB Vitamin B12 Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 4 | 00630414603100 | 10995088 | 10995088 | Active B12 - RGT - CENTAUR - 100T | ADVIA Centaur® Active B12 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 5 | 00630414600314 | 10995718 | 10995718 | Vitamin B12 (VB12) DTT/REL Atellica IM - CONS | Atellica IM VB12 DTT/REL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 6 | 00630414600307 | 10995717 | 10995717 | Vitamin B12 (VB12) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL | Atellica IM VB12 MCM | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 7 | 00630414600291 | 10995716 | 10995716 | Vitamin B12 (VB12) Diluent Atellica IM - CONS (2PK) 2 x 5mL | Atellica IM VB12 DIL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 8 | 00630414600284 | 10995715 | 10995715 | Vitamin B12 (VB12) Atellica IM - RGT 500T | Atellica IM VB12 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 9 | 00630414600277 | 10995714 | 10995714 | Vitamin B12 (VB12) Atellica IM - RGT 100T | Atellica IM VB12 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 10 | 00630414598611 | 10995534 | 10995534 | CKMB - Atellica IM - Master Curve Material Kit 10 x 1 x 1.0mL | Atellica IM CKMB MCM | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 11 | 00630414598345 | 10995507 | 10995507 | Calibrator C - Atellica IM - CAL (6PK) 6 x 2 x 5.0 mL | Atellica IM Calibrator C | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 12 | 00630414598338 | 10995506 | 10995506 | Calibrator C - Atellica IM - CAL (2PK) 2 x 2 x 5.0mL | Atellica IM Calibrator C | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 13 | 00630414443010 | 10310330 | 121093 | Vitamin B12 RA Kit - CENTAUR - CONS - 1 Kit | ADVIA Centaur® VB12 DTT/Releasing Agent | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 14 | 00630414293820 | 11206264 | 11206264 | Vitamin B12 (VB12) - Atellica IM - RGT 500T | Atellica IM VB12 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 15 | 00630414293554 | 11206243 | 11206243 | Calibrator C - Atellica IM - CAL (6PK) 6 x 2 x 5.0 mL | Atellica IM Calibrator C | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 16 | 00630414245720 | 10733001 | 10733001 | Active-B12 (AB12) Atellica IM - RGT 100T | Atellica IM AB12 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 17 | 00630414204758 | 10336453 | 118806 | ADVIA Centaur® VB12 (5-pack) | ADVIA Centaur® VB12 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 18 | 00630414177175 | 10330218 | 110748 | Vitamin B12 - CENTAUR - RGT - 500 tests | ADVIA Centaur® VB12 +C | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 19 | 00630414177168 | 10309970 | 110747 | Vitamin B12 - CENTAUR - RGT - 100 tests | ADVIA Centaur® VB12 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 20 | 00630414175300 | 10309949 | 110321 | VitaminB 12 Dil.RP (2PK) - CENTAUR - CAL - 2x5mL | ADVIA Centaur® VB12 Diluent | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 21 | 00630414124926 | 10334728 | 672182005 | Ferritin/VitB12 (Ref) - CENTAUR - CAL - 6x2x5mL | ADVIA Centaur® Calibrator C | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 22 | 00630414124919 | 10311575 | 672182000 | Ferritin/VitB12 - CENTAUR - CAL - 6x2x5mL | ADVIA Centaur® Systems, ACS:180® Systems Calibrator C | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 23 | 00630414124780 | 10311568 | 672172000 | Ferritin/VitB12 - CENTAUR - CAL - 2x2x5mL | ADVIA Centaur® Calibrator C | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 24 | 00630414056098 | 10309782 | 105805 | CK-MB 2 Master Curve Material - CENTAUR - CONS | ADVIA Centaur® CKMB MCM | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 25 | 00630414054124 | 10309760 | 104523 | Vitamin B12 - Master Curve Material Set - CENTAUR - CONS | ADVIA Centaur® VB12 MCM | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 26 | 00380740150525 | 09P2620 | 09P2620 | Alinity i Active-B12 (Holotranscobalamin) Reagent Kit 200 Tests | Alinity | ABBOTT GMBH |
| 27 | 00380740136703 | 07P6731 | 07P6731 | Alinity i B12 Reagent Kit 1200 Tests | Alinity | ABBOTT IRELAND |
| 28 | 00380740136697 | 07P6721 | 07P6721 | Alinity i B12 Reagent Kit 200 Tests | Alinity | ABBOTT IRELAND |
| 29 | 00380740014193 | 7K61-37 | 07K6137 | ARCHITECT B12 Reagent Kit (500T) | ARCHITECT | ABBOTT IRELAND |
| 30 | 00380740014179 | 7K61-27 | 07K6127 | ARCHITECT B12 Reagent Kit (100T) | ARCHITECT | ABBOTT IRELAND |
| 31 | 00380740014155 | 7K61-12 | 07K6112 | ARCHITECT B12 Controls | ARCHITECT | ABBOTT IRELAND |
| 32 | 00380740014131 | 7K61-02 | 07K6102 | ARCHITECT B12 Calibrators | ARCHITECT | ABBOTT IRELAND |
| 33 | 00380740006365 | 3P24-25 | 03P2425 | ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit | ARCHITECT | ABBOTT GMBH |
| 34 | 00380740006358 | 3P24-10 | 03P2410 | ARCHITECT Active-B12 (Holotranscobalamin) Controls | ARCHITECT | ABBOTT GMBH |
| 35 | 00380740006341 | 3P24-01 | 03P2401 | ARCHITECT Active-B12 (Holotranscobalamin) Calibrators | ARCHITECT | ABBOTT GMBH |
| 36 | 15099590224325 | 33005 | 33005 | The Access Vitamin B12 Calibrators are intended to calibrate the Access Vitamin The Access Vitamin B12 Calibrators are intended to calibrate the Access Vitamin B12 assay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. | Access Vitamin B12 Calibrators | BECKMAN COULTER, INC. |
| 37 | 15099590224318 | 33006 | 33006 | The Access Vitamin B12 Calibrator S0 is intended for use with Access Vitamin B12 The Access Vitamin B12 Calibrator S0 is intended for use with Access Vitamin B12 to dilute patient samples containing analyte concentrations greater than the analyte specic S5 calibrator. | Access Vitamin B12 Calibrator S0 | BECKMAN COULTER, INC. |
| 38 | 14560189211879 | N/A | AIA-PACK B12 | TOSOH CORPORATION | ||
| 39 | 10758750009367 | 1540525 | 1540525 | VITROS Immunodiagnostic Products Vitamin B12 Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 40 | 10758750009138 | 1453489 | 1453489 | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 41 | 10758750008476 | 1142561 | 1142561 | VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3 | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 42 | 08056771602532 | 318320 | LIAISON® Vitamin B12 | DIASORIN INC. | ||
| 43 | 05055845400046 | FMABT100 | FMABT100 | The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay ( The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency. | Axis-Shield Active-B12 (Holotranscobalamin) EIA | AXIS-SHIELD DIAGNOSTICS LIMITED |
| 44 | 04560189211902 | N/A | AIA-PACK B12 Sample Diluting Solution | TOSOH CORPORATION | ||
| 45 | 04560189211896 | N/A | AIA-PACK B12 Pretreatment Set | TOSOH CORPORATION | ||
| 46 | 04560189211889 | N/A | AIA-PACK B12 Calibrator Set | TOSOH CORPORATION | ||
| 47 | H628330001 | 33000 | 33000 | Access Vitamin B12 | BECKMAN COULTER, INC. | |
| 48 | 04049325008304 | AX53101 | AX53101 | Active-B12 (Holotranscobalamin) ELISA - 96 determinations | Active-B12 (Holotranscobalamin) ELISA | IBL INTERNATIONAL GMBH |
| 49 | 04015630940684 | 07212771160 | 07212771160 | Elecsys Vitamin B12 II | ROCHE DIAGNOSTICS GMBH | |
| 50 | 04015630939848 | 07028121190 | 07028121190 | Elecsys Vitamin B12 II | ROCHE DIAGNOSTICS GMBH |