| 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 | 00857969006303 | SA2002 | SA2002 | Alkaline Phosphatase Reagent | ACE | ALFA WASSERMANN, INC. |
| 2 | 00857969006297 | RX2002 | RX2002 | Alkaline Phosphatase Reagent | ACE | ALFA WASSERMANN, INC. |
| 3 | 00852169008027 | ALP1010 | ALP1010 | In Vitro Diagnostics testing kit R1:3X48mL, R2:3X12mL | ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP) | CLEARCHEM DIAGNOSTICS INC. |
| 4 | 00851445007037 | GEN-ALP R2 | GEN-ALP R2 | 10/17/2022 | GENCHEM™ Alkaline Phosphatase | GENCHEM INC |
| 5 | 00851445007020 | GEN-ALP R1 | GEN-ALP R1 | 10/17/2022 | GENCHEM™ Alkaline Phosphatase | GENCHEM INC |
| 6 | 00845275000412 | TR11320 | Thermo Scientific | FISHER DIAGNOSTICS | ||
| 7 | 00817439020147 | ALP600 | ALP600 | For the quantitative determination of alkaline phosphatase in human serum using For the quantitative determination of alkaline phosphatase in human serum using the Mindray BS-200 analyzer. For in vitro diagnostic use only.100 ml kit | MedTest DX Alkaline Phosphatase | MEDTEST DX, INC. |
| 8 | 00817439020130 | ALP505 | ALP505 | For the quantitative in vitro determination of Alkaline Phosphatase (ALP) in ser For the quantitative in vitro determination of Alkaline Phosphatase (ALP) in serum and plasma. 6 x 51 ml, 6 x 14 ml | ALP Reagent | MEDTEST DX, INC. |
| 9 | 00817439020123 | ALP480 | ALP480 | For the quantitative determination of Albumin in serum using the Mindray BS-480 For the quantitative determination of Albumin in serum using the Mindray BS-480 analyzer. In vitro diagnostic medical device.3 x 60 ml, 3 x 15 ml | Alkaline Phos/ BS480 | MEDTEST DX, INC. |
| 10 | 00817302023015 | DT206 | DT206 | ALP (Alkaline Phosphatase) 4 x 275 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ALP REAGENT PRODUCT NO. DT206 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 11 | 00817302020267 | CC206 | CC206 | ALP (Alkaline Phosphatase) 2 x 200 tests. | CAROLINA LIQUID CHEMISTRIES CORP.® ALP ALKALINE PHOSPHATASE REAGENT CC206 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 12 | 00817302020250 | BL206 | BL206 | ALP (Alkaline Phosphatase) 3 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ALP RGT.KIT BL-206 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 13 | 00817302020243 | AU-206 | AU-206 | ALP (Alkaline Phosphatase) 3 x 250 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ALP RGT.KIT AU-206 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 14 | 00817302020236 | ST206 | ST206 | ALP (Alkaline Phosphatase) 4 x 200 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 ALP RGT KIT Product No. ST206 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 15 | 00817274022443 | ALP2-BUL-R2 | ALP2-BUL-R2 | Alkaline Phosphatase Bulk Liquid R1 2.5 L | JAS Diagnostics | DREW SCIENTIFIC, INC. |
| 16 | 00817274022436 | ALP2-BUL-R1 | ALP2-BUL-R1 | Alkaline Phosphatase Bulk Liquid R1 10 L | JAS Diagnostics | DREW SCIENTIFIC, INC. |
| 17 | 00817274020739 | ALT2-P1L | ALT 1L PALS | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 18 | 00817274020722 | ALP2-30R2U | ALP R2 (1x 30mL) UV | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 19 | 00817274020715 | ALP2-120R1U | ALP R1 (1x 120mL) Unlabeled Vial | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 20 | 00817274020708 | XL-ALP2-40 | ALP LIQUID REAGENT (5 x 40 mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 21 | 00817274020692 | ALP2-1L | ALP LIQUID (1x 1L R1, 2x 125mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 22 | 00817274020685 | ALP2-120 | ALP LIQUID (1x 120mL R1, 1x 30mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 23 | 00812137011855 | R1 x 500 mL, R2 x 125 mL | 501-398 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. Serum alkaline phosphatase estimations are of interest in the diagnosis of two groups of conditions; hepatobiliary disease and bone disease associated with increased osteoblastic activity. | Alkaline Phosphatase Reagent Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
| 24 | 00811727016010 | 16-A7516-252 | 16-A7516-252 | Pointe Alkaline Phosphatase Reagent packaged for use on the Mindray BA800. 4 x 5 Pointe Alkaline Phosphatase Reagent packaged for use on the Mindray BA800. 4 x 50ml R1, 4 x 13ml R2. For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | Pointe Alkaline Phosphatase Reagent | POINTE SCIENTIFIC, INC. |
| 25 | 00811727015709 | 14-A7516-225 | 14-A7516-225 | Pointe Alkaline Phosphatase packaged for the BS480 Analyzer. 3x60mL, 3x15mL kit Pointe Alkaline Phosphatase packaged for the BS480 Analyzer. 3x60mL, 3x15mL kit. For the quantitative determination of alkaline phosphatase in human serum on the BS480 Analyzer.. For in vitro diagnostic use only. | Pointe Alkaline Phosphatase on the BS480 | POINTE SCIENTIFIC, INC. |
| 26 | 00811727014597 | HA716-2400 | HA716-2400 | Alkaline Phosphatase Reagent, for the quantitative determination of alkaline pho Alkaline Phosphatase Reagent, for the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. Size: 1 x 2 L, 1 x 400 mL | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 27 | 00811727013743 | 13-A7516-R2-30 | 13-A7516-R2-30 | For the quantitative determination of Alanine Aminotransferase in serum. | Alk Phos R2 (w/ssa#) | POINTE SCIENTIFIC, INC. |
| 28 | 00811727013736 | 13-A7516-R2-125 | 13-A7516-R2-125 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | Alk Phos R2 (w/ssa#) | POINTE SCIENTIFIC, INC. |
| 29 | 00811727013729 | 13-A7516-R1-500 | 13-A7516-R1-500 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | Alk Phos R1 (w/ssa#) | POINTE SCIENTIFIC, INC. |
| 30 | 00811727013712 | 13-A7516-R1-120 | 13-A7516-R1-120 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | Alk Phos R1 (w/ssa#) | POINTE SCIENTIFIC, INC. |
| 31 | 00811727013392 | 12-A7516-100 | 12-A7516-100 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | POINTE SCIENTIFIC Alkaline Phosphatase | POINTE SCIENTIFIC, INC. |
| 32 | 00811727012876 | HA916-302 | HA916-302 | Alkaline Phosphatase Reagent, for the quantitative determination of alkaline pho Alkaline Phosphatase Reagent, for the quantitative determination of alkaline phosphatase in human serum on Hitachi analyzers. For in vitro diagnostic use only. Size: 5 x 50mL, 4 x 13mL | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 33 | 00811727012531 | HA916-492 | HA916-492 | Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline phosphatase in human serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 4 x 100ml, 4 x 23ml | Pointe Scientific Inc. | POINTE SCIENTIFIC, INC. |
| 34 | 00811727010155 | A7516-625 | A7516-625 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) | POINTE SCIENTIFIC, INC. |
| 35 | 00811727010148 | A7516-450 | A7516-450 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) | POINTE SCIENTIFIC, INC. |
| 36 | 00811727010131 | A7516-150 | A7516-150 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) | POINTE SCIENTIFIC, INC. |
| 37 | 00657498001646 | S2900-600 | S2900-600 | For the Kinetic Quantitative Determination of Alkaline Phosphatase in Serum or Plasma. | Sirrus® Alkaline Phosphatase LiquiColor® | STANBIO LABORATORY, L.P. |
| 38 | 00657498000458 | 2900-500 | 2900-500 | For the Kinetic Quantitative Determination of Alkaline Phosphatase in Serum for For the Kinetic Quantitative Determination of Alkaline Phosphatase in Serum for Manual and/or Automated Procedures. | Alkaline Phosphatase LiquiColor® | STANBIO LABORATORY, L.P. |
| 39 | 00657498000441 | 2900-430 | 2900-430 | For the Kinetic Quantitative Determination of Alkaline Phosphatase in Serum for For the Kinetic Quantitative Determination of Alkaline Phosphatase in Serum for Manual and/or Automated Procedures. | Alkaline Phosphatase LiquiColor® | STANBIO LABORATORY, L.P. |
| 40 | 00628063401192 | SK328-40 | SK328-40 | Alkaline Phosphatase | SEKISUI DIAGNOSTICS, LLC | |
| 41 | 00628063400096 | SK328-20 | SK328-20 | ALKALINE PHOSPHATASE | SEKISUI DIAGNOSTICS, LLC | |
| 42 | 00628063400089 | 328-30 | 328-30 | ALKALINE PHOSPHATASE-SL | SEKISUI DIAGNOSTICS, LLC | |
| 43 | 00386100002107 | 10214-4 | 10214-4 | Alkaline Phosphatase Reagent Kit for use with EasyRA Analyzers | ALP Reagent Kit | MEDICA CORPORATION |
| 44 | 00380740150907 | 7D55-32 | 07D5532 | Alkaline Phosphatase | ARCHITECT | ABBOTT GMBH |
| 45 | 00380740150891 | 7D55-22 | 07D5522 | Alkaline Phosphatase | ARCHITECT | ABBOTT GMBH |
| 46 | 00380740135171 | 08P2030 | 08P2030 | Alinity c Alkaline Phosphatase Reagent Kit 10750 Tests | Alinity | ABBOTT GMBH |
| 47 | 00380740135164 | 08P2020 | 08P2020 | Alinity c Alkaline Phosphatase Reagent Kit 4000 Tests | Alinity | ABBOTT GMBH |
| 48 | 00380740012830 | 7D55-31 | 07D5531 | Alkaline Phosphatase | ARCHITECT | ABBOTT LABORATORIES |
| 49 | 00380740012823 | 7D55-21 | 07D5521 | Alkaline Phosphatase | ARCHITECT | ABBOTT LABORATORIES |
| 50 | 15099590625689 | 476821 | 476821 | Alkaline Phosphatase Reagent (ALP 2 x 400) | Synchron | BECKMAN COULTER, INC. |