| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00380740059941 | 6E66-58 | 06E6658 | ABBOTT PRISM HBcore Wash Kit | ABBOTT PRISM | |||
| 2 | 00380740059934 | 3L68-58 | 03L6858 | ABBOTT PRISM HIV O Plus Wash Kit | ABBOTT PRISM | |||
| 3 | 00380740059927 | 7K35-58 | 07K3558 | ABBOTT PRISM Chagas Wash Kit | ABBOTT PRISM | |||
| 4 | 00380740050375 | 7A03-30 | 07A0330 | ABBOTT PRISM Purge Concentrate | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 5 | 00380740027056 | 7A03-01 | 07A0301 | ABBOTT PRISM Prime/Purge Accessories | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 6 | 00380740027001 | 1A75-01 | 01A7501 | ABBOTT PRISM Activator Diluent | ABBOTT PRISM | |||
| 7 | 00380740012403 | 7B36-01 | 07B3601 | ABBOTT PRISM SAMPLE CUPS | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 8 | 00380740011604 | 7A03-31 | 07A0331 | ABBOTT PRISM Line Cleaner | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 9 | 00380740008574 | 6A36-34 | 06A3634 | ABBOTT PRISM NEXT MAIN INSTRUMENT SIX CHANNEL | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 10 | 00380740008420 | 6A36-11 | 06A3611 | ABBOTT PRISM NEXT MAIN INSTRUMENT SIX CHANNEL | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 11 | 00380740007911 | 5A07-10 | 05A0710 | ABBOTT PRISM Pipette Tips | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 12 | 00380740007904 | 5A07-01 | 05A0701 | ABBOTT PRISM Reaction Trays | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 13 | 00380740168209 | 01P0603 | 01P0603 | Transplant Pretreatment Tubes | MLM,MKW,NRP | ENZYME IMMUNOASSAY, TRACROLIMUS,CYCLOSPORINE,Sirolimus test system | Alinity-Architect | |
| 14 | 00380740138400 | 3R97-02 | 03R9702 | ABBOTT PRISM Director Version 2.1 | MTQ | Software, blood virus applications | ABBOTT PRISM | |
| 15 | 00380740138394 | 3R97-01 | 03R9701 | ABBOTT PRISM Director Version 2.0 | MTQ | Software, blood virus applications | ABBOTT PRISM | |
| 16 | 00380740137922 | 09D2804 | 09D2804 | ICT Module | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity-Architect |
| 17 | 00380740063016 | 6E50-68 | 06E5068 | ABBOTT PRISM HTLV-I/HTLV-II Assay Kit | ABBOTT PRISM | |||
| 18 | 00380740062996 | 6D18-68 | 06D1868 | ABBOTT PRISM HCV Assay Kit | ABBOTT PRISM | |||
| 19 | 00380740062989 | 6D19-68 | 06D1968 | ABBOTT PRISM HBsAg Assay Kit | ABBOTT PRISM | |||
| 20 | 00380740062972 | 6E51-68 | 06E5168 | ABBOTT PRISM HBsAg Confirmatory Assay Kit | ABBOTT PRISM | |||
| 21 | 00380740062965 | 6E66-68 | 06E6668 | ABBOTT PRISM HBcore Assay Kit | ABBOTT PRISM | |||
| 22 | 00380740062958 | 3L68-68 | 03L6868 | ABBOTT PRISM HIV O Plus Assay Kit | ABBOTT PRISM | |||
| 23 | 00380740062941 | 7K35-68 | 07K3568 | ABBOTT PRISM Chagas Assay Kit | ABBOTT PRISM | |||
| 24 | 00380740038403 | 3E60-10 | 03E6010 | ABBOTT PRISM Run Control Kit | ABBOTT PRISM | |||
| 25 | 00380740059972 | 6E50-58 | 06E5058 | ABBOTT PRISM HTLV-I/HTLV-II Wash Kit | ABBOTT PRISM | |||
| 26 | 00380740059965 | 6D18-58 | 06D1858 | ABBOTT PRISM HCV Wash Kit | ABBOTT PRISM | |||
| 27 | 00380740059958 | 6D19-58 | 06D1958 | ABBOTT PRISM HBsAg Wash Kit | ABBOTT PRISM | |||
| 28 | 00380740039219 | 3E60-11 | 03E6011 | ABBOTT PRISM Positive Run Control Kit | ABBOTT PRISM | |||
| 29 | 00380740038380 | 6L86-10 | 06L8610 | ABBOTT PRISM Chagas Run Control Kit | ABBOTT PRISM | |||
| 30 | 00380740038373 | 1A75-10 | 01A7510 | ABBOTT PRISM Activator Line Treatment | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 31 | 00380740030445 | 1A75-02 | 01A7502 | ABBOTT PRISM Activator Concentrate | ABBOTT PRISM | |||
| 32 | 00380740089535 | 8L34-68 | 08L3468 | ABBOTT ESA Chagas Assay Kit | ABBOTT | |||
| 33 | 00380740011635 | 7A12-60 | 07A1260 | XSYSTEMS TDx/TDx Flx Methotrexate II Reagent Pack | LAO | Enzyme immunoassay, methotrexate | U | ABBOTT |
| 34 | 00380740011628 | 7A12-10 | 07A1210 | XSYSTEMS TDx/TDx Flx Methotrexate II Controls | LAO | Enzyme immunoassay, methotrexate | U | ABBOTT |
| 35 | 00380740011611 | 7A12-01 | 07A1201 | XSYSTEMS TDx/TDx Flx Methotrexate II Calibrators | LAO | Enzyme immunoassay, methotrexate | U | ABBOTT |
| 36 | 00380740136093 | 04R1301 | 04R1301 | Emerald 22 Autoloader Analyzer | GKZ | Counter, differential cell | 2 | CELL-DYN |
| 37 | 00380740135737 | 99326-02 | 9932602 | CELL-DYN 1800 System DETERGENT | JCB | DETERGENT | 1 | CELL-DYN |
| 38 | 00380740135720 | 01H78-02 | 01H7802 | CELL-DYN Sapphire System WBC REAGENT - PART B | GGK | PRODUCTS, RED-CELL LYSING PRODUCTS | 1 | CELL-DYN |
| 39 | 00380740135713 | 01H77-02 | 01H7702 | CELL-DYN Sapphire System WBC REAGENT - PART A | GGK | PRODUCTS, RED-CELL LYSING PRODUCTS | 1 | CELL-DYN |
| 40 | 00380740120788 | 09H62-01 | 09H6201 | CELL-DYN Emerald 22 Diluent | GIF | DILUENT, BLOOD CELL | 1 | CELL-DYN |
| 41 | 00380740120771 | 09H6101 | 09H6101 | CELL-DYN Emerald 22 Lyse | GGK | PRODUCTS, RED-CELL LYSING PRODUCTS | 1 | CELL-DYN |
| 42 | 00380740120764 | 09H60-01 | 09H6001 | CELL-DYN Emerald 22 Easy Cleaner | JCB | DETERGENT | 1 | CELL-DYN |
| 43 | 00380740119843 | 09H73-01 | 09H7301 | CELL-DYN 22 Plus Calibrator | KRX | CALIBRATOR FOR CELL INDICES | 2 | CELL-DYN |
| 44 | 00380740119836 | 09H72-02 | 09H7202 | CELL-DYN 22 Plus Control | GLQ | MIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES | 2 | CELL-DYN |
| 45 | 00380740119829 | 09H72-01 | 09H7201 | CELL-DYN 22 Plus Control | GLQ | MIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES | 2 | CELL-DYN |
| 46 | 00380740099916 | 08H67-03 | 08H6703 | CELL-DYN Ruby | GKZ | Counter, differential cell | 2 | CELL-DYN |
| 47 | 00380740072643 | 07H84-02 | 07H8402 | CELL-DYN 1800 System CN-FREE DIFF LYSE | GGK | PRODUCTS, RED-CELL LYSING PRODUCTS | 1 | CELL-DYN |
| 48 | 00380740072445 | 99220-02 | 9922002 | CELL-DYN 1800 System DILUENT | GIF | DILUENT, BLOOD CELL | 1 | CELL-DYN |
| 49 | 00380740071141 | 07H77-01 | 07H7701 | CELL-DYN 1800 | GKZ | Counter, differential cell | 2 | CELL-DYN |
| 50 | 00380740021085 | 99644-01 | 9964401 | ENZYM CLNR 2X50 ML | JCB | DETERGENT | 1 | CELL-DYN |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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. |
| 2 | 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. |
| 3 | 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. |
| 4 | 00817302023015 | DT206 | DT206 | ALP (Alkaline Phosphatase) 4 x 275 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ALP REAGENT PRODUCT NO. DT206 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 5 | 00817302020267 | CC206 | CC206 | ALP (Alkaline Phosphatase) 2 x 200 tests. | CAROLINA LIQUID CHEMISTRIES CORP.® ALP ALKALINE PHOSPHATASE REAGENT CC206 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 6 | 00817302020250 | BL206 | BL206 | ALP (Alkaline Phosphatase) 3 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ALP RGT.KIT BL-206 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 7 | 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 |
| 8 | 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 |
| 9 | 00817274022443 | ALP2-BUL-R2 | ALP2-BUL-R2 | Alkaline Phosphatase Bulk Liquid R1 2.5 L | JAS Diagnostics | DREW SCIENTIFIC, INC. |
| 10 | 00817274022436 | ALP2-BUL-R1 | ALP2-BUL-R1 | Alkaline Phosphatase Bulk Liquid R1 10 L | JAS Diagnostics | DREW SCIENTIFIC, INC. |
| 11 | 00817274020739 | ALT2-P1L | ALT 1L PALS | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 12 | 00817274020722 | ALP2-30R2U | ALP R2 (1x 30mL) UV | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 13 | 00817274020715 | ALP2-120R1U | ALP R1 (1x 120mL) Unlabeled Vial | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 14 | 00817274020708 | XL-ALP2-40 | ALP LIQUID REAGENT (5 x 40 mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 15 | 00817274020692 | ALP2-1L | ALP LIQUID (1x 1L R1, 2x 125mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 16 | 00817274020685 | ALP2-120 | ALP LIQUID (1x 120mL R1, 1x 30mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 17 | 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. |
| 18 | 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. |
| 19 | 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. |
| 20 | 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. |
| 21 | 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. |
| 22 | 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. |
| 23 | 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. |
| 24 | 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. |
| 25 | 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. |
| 26 | 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. |
| 27 | 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. |
| 28 | 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. |
| 29 | 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. |
| 30 | 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. |
| 31 | 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. |
| 32 | 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. |
| 33 | 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. |
| 34 | 00628063401192 | SK328-40 | SK328-40 | Alkaline Phosphatase | SEKISUI DIAGNOSTICS, LLC | |
| 35 | 00628063400096 | SK328-20 | SK328-20 | ALKALINE PHOSPHATASE | SEKISUI DIAGNOSTICS, LLC | |
| 36 | 00628063400089 | 328-30 | 328-30 | ALKALINE PHOSPHATASE-SL | SEKISUI DIAGNOSTICS, LLC | |
| 37 | 00386100002107 | 10214-4 | 10214-4 | Alkaline Phosphatase Reagent Kit for use with EasyRA Analyzers | ALP Reagent Kit | MEDICA CORPORATION |
| 38 | 00380740150907 | 7D55-32 | 07D5532 | Alkaline Phosphatase | ARCHITECT | ABBOTT GMBH |
| 39 | 00380740150891 | 7D55-22 | 07D5522 | Alkaline Phosphatase | ARCHITECT | ABBOTT GMBH |
| 40 | 00380740135171 | 08P2030 | 08P2030 | Alinity c Alkaline Phosphatase Reagent Kit 10750 Tests | Alinity | ABBOTT GMBH |
| 41 | 00380740135164 | 08P2020 | 08P2020 | Alinity c Alkaline Phosphatase Reagent Kit 4000 Tests | Alinity | ABBOTT GMBH |
| 42 | 00380740012830 | 7D55-31 | 07D5531 | Alkaline Phosphatase | ARCHITECT | ABBOTT LABORATORIES |
| 43 | 00380740012823 | 7D55-21 | 07D5521 | Alkaline Phosphatase | ARCHITECT | ABBOTT LABORATORIES |
| 44 | 15099590625689 | 476821 | 476821 | Alkaline Phosphatase Reagent (ALP 2 x 400) | Synchron | BECKMAN COULTER, INC. |
| 45 | 15099590575168 | 442670 | 442670 | Alkaline Phosphatase Reagent (ALP 2 x 200) | Synchron | BECKMAN COULTER, INC. |
| 46 | 15099590060015 | OSR6604 | ALP | AU | BECKMAN COULTER, INC. | |
| 47 | 15099590020019 | OSR6204 | ALP | AU | BECKMAN COULTER, INC. | |
| 48 | 15099590010034 | OSR6104 | ALP | AU | BECKMAN COULTER, INC. | |
| 49 | 15099590000028 | OSR6004 | ALP | AU | BECKMAN COULTER, INC. | |
| 50 | 10758750031801 | 6844296 | 6844296 | VITROS XT Chemistry Products TBIL-ALKP Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |