| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00380740200053 | 08P433C | 08P433C | Alinity c A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 2 | 00380740200060 | 09P271B | 09P271B | Alinity i Anti-CCP Assay File | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Alinity |
| 3 | 00380740200046 | 08P435C | 08P435C | Alinity c %A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 4 | 00380740200039 | 08P431C | 08P431C | Alinity c A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 5 | 00380740200022 | 08P437C | 08P437C | Alinity c %A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 6 | 00380740199487 | 04V511B | 04V511B | Alinity c Total Bilirubin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 7 | 00380740195458 | 07P701C | 07P701C | Alinity i Free T4 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 8 | 00380740195380 | 08P181B | 08P181B | Alinity c A-ALT Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 9 | 00380740194208 | 09P523B | 09P523B | Alinity c BenzSQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 10 | 00380740194192 | 09P521B | 09P521B | Alinity c BenzQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 11 | 00380740194093 | 06S611A | 06S611A | Alinity i COV 2IgGII Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 12 | 00380740193638 | 04Z211A | 04Z211A | Alinity i STAT High Sensitivity Tropopnin-I | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 13 | 00380740193577 | 07P701B | 07P701B | Alinity i Free T4 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 14 | 00380740192723 | 04U093A | 04U093A | Alinity c Uric2-U Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 15 | 00380740192464 | 06R911A | 06R911A | Alinity i COV-2 IgM Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 16 | 00380740189105 | 08P013B | 08P013B | Alinity c CrEnzU Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 17 | 00380740189099 | 08P011B | 08P011B | Alinity c CrEnz Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 18 | 00380740186418 | 04T843A | 04T843A | Alinity c ALT2F Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 19 | 00380740186401 | 04T841A | 04T841A | Alinity c ALT2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 20 | 00380740186395 | 04T863A | 04T863A | Alinity c AST2F Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 21 | 00380740186388 | 04T861A | 04T861A | Alinity c AST2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 22 | 00380740186364 | 04U091A | 04U091A | Alinity c Uric2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 23 | 00380740186265 | 04T961A | 04T961A | Alinity c GGT2 Asasy File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 24 | 00380740186159 | 04T811A | 04T811A | Alinity c TPRO2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 25 | 00380740185978 | 07P569A | 07P569A | Alinity c CardiacCRP Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 26 | 00380740185787 | 09P261B | 09P261B | Alinity i Active B12 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 27 | 00380740181000 | 09P533A | 09P533A | Alinity c SerBENZQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 28 | 00380740180201 | 08P433B | 08P433B | Alinity c A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 29 | 00380740180195 | 08P435B | 08P435B | Alinity c %A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 30 | 00380740180188 | 08P431B | 08P431B | Alinity c A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 31 | 00380740180171 | 08P437B | 08P437B | Alinity c %A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 32 | 00380740180164 | 08P541B | 08P541B | Alinity c Phenytoin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 33 | 00380740180157 | 08P591B | 08P591B | Alinity c Salicylate Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 34 | 00380740180140 | 08P193C | 08P193C | Alinity c MagnesiumU Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 35 | 00380740180133 | 08P191C | 08P191C | Alinity c Magnesium Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 36 | 00380740180126 | 09P631B | 09P631B | Alinity c IgM Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 37 | 00380740180119 | 08P531D | 08P531D | Alinity c Lithium Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 38 | 00380740180089 | 08P041B | 08P041B | Alinity c Microalb Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 39 | 00380740180058 | 08P551B | 08P551B | Alinity c Gentamicin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 40 | 00380740180041 | 09P931B | 09P931B | Alinity c Cerulo Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 41 | 00380740180034 | 07P591B | 07P591B | Alinity c U/CSF Prot Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 42 | 00380740180027 | 07P751B | 07P751B | Alinity c Ultra HDL Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 43 | 00380740180010 | 07P771B | 07P771B | Alinity c Trig Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 44 | 00380740180003 | 09P861B | 09P861B | Alinity c Prealbumin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 45 | 00380740179991 | 07P761B | 07P761B | Alinity c Chol Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 46 | 00380740179984 | 08P021B | 08P021B | Alinity c AlbuminBCG Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 47 | 00380740179977 | 07P691C | 07P691C | Alinity i Free T3 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 48 | 00380740179960 | 07P941C | 07P941C | Alinity i Total T3 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 49 | 00380740179571 | 07P567A | 07P567A | Alinity c CRP WR Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 50 | 00380740179564 | 07P565A | 07P565A | Alinity c CRP HS Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 15099590221171 | 447450 | 447450 | IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent | IMMAGE | BECKMAN COULTER, INC. |
| 2 | M2045020010 | 502-001 | 502-001 | TorqMax™ Sheath Grip Assembly | TorqMax™ | SPECTRANETICS CORPORATION |
| 3 | 07613336140833 | 08106126190 | 08106126190 | Tina-quant Lipoprotein (a) Gen.2 | ROCHE DIAGNOSTICS GMBH | |
| 4 | 07613336133538 | 08105464190 | 08105464190 | Tina-quant Apolipoprotein B ver.2 | ROCHE DIAGNOSTICS GMBH | |
| 5 | 05391516743938 | 2339100 | 2339100 | Macra® Lp(a) | Trinity Biotech | CLARK LABORATORIES, INC. |
| 6 | 05055845400022 | FHCY200 | FHCY200 | The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed qu The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total L-homocysteine in human serum or plasma. | Axis-Shield Homocysteine Controls | AXIS-SHIELD DIAGNOSTICS LIMITED |
| 7 | 05055845400015 | FHCY100 | FHCY100 | The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. | Axis® Homocysteine EIA | AXIS-SHIELD DIAGNOSTICS LIMITED |
| 8 | 05055273209198 | LP2757 | LP2757 | Immunoturbidimetric assay for the quantitative in vitro determination of Lipopro Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma. | Lp (a) | RANDOX LABORATORIES LIMITED |
| 9 | 05055273204445 | LP3406 | Randox Lipoprotein(a) level 3 control is based on lyophilised human serum contai Randox Lipoprotein(a) level 3 control is based on lyophilised human serum containing Lipoprotein(a). | LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3) | RANDOX LABORATORIES LIMITED | |
| 10 | 05055273204421 | LP3403 | LP3403 | Immunoturbidimetric assay for the quantitative in vitro determination of Lipopro Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma. | Lp (a) | RANDOX LABORATORIES LIMITED |
| 11 | 05055273204384 | LP2878 | LP2878 | For the quantitative in vitro determination of Lipoprotein (a) in human serum or plasma. | Lp (a) | RANDOX LABORATORIES LIMITED |
| 12 | 05051700016841 | LK098.S | Lipoprotein (a) Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | ||
| 13 | 04015630930586 | 5852633190 | 5852633190 | Tinaquant Lipoprotein a Gen.2 | ROCHE DIAGNOSTICS GMBH | |
| 14 | 04015630930234 | 6301711190 | 6301711190 | Tinaquant Apolipoprotein B ver2 | ROCHE DIAGNOSTICS GMBH | |
| 15 | 04015630929962 | 5852625190 | 5852625190 | Tinaquant Lipoprotein a Gen.2 | ROCHE DIAGNOSTICS GMBH | |
| 16 | 04015630928668 | 5950694190 | 5950694190 | Tinaquant Apolipoprotein B ver2 | ROCHE DIAGNOSTICS GMBH | |
| 17 | 04015630917754 | 3032639122 | 3032639122 | Tinaquant Apolipoprotein B ver2 | ROCHE DIAGNOSTICS GMBH | |
| 18 | 04015630917730 | 3032574122 | 3032574122 | Tinaquant Apolipoprotein B ver2 | ROCHE DIAGNOSTICS GMBH | |
| 19 | 00842768007552 | 10446069 | OQHL11 | Quantitative determination of Lp(a) in human serum and heparinized plasma on BN Systems | N Latex Lp(a) Reagent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 20 | 00817439021090 | LPAC480 | LPAC480 | Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calib Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calibration of Lipoprotein(a). 5 x 1 ml. | MedTest DX Lipoprotein (a) Calibrator for the BS480 | MEDTEST DX, INC. |
| 21 | 00817439021069 | LPA480 | LPA480 | The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determ The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples on the Mindray BS-480. The measurement of Lp(a) is useful in assessing lipid metabolism disorders and atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.4 x 40 ml, 4 x 14 ml | MedTest Dx, Inc. Lp (a) | MEDTEST DX, INC. |
| 22 | 00817302022315 | BL-204B | BL-204B | Lp (a) Lipoprotein BL-204B | CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 23 | 00817302022308 | AU-204B | AU-204B | Lp (a) Lipoprotein AU-204B | CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 24 | 00817302020151 | CC204-100-D | CC204-100-D | Lp(a) (Lipoprotein (a) 2 x 60 tests | CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 25 | 00817302020144 | AU-204-D | AU-204-D | Lp(a) (Lipoprotein (a) 3 x 400 tests | CAROLINA LIQUID CHEMISTRIES CORP.® LP(a)-D RGT. KIT AU-204-D | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 26 | 00817302020137 | BL204 | BL204 | Lp(a) (Lipoprotein (a) 2 x 130 tests | CAROLINA LIQUID CHEMISTRIES CORP.® LP(a) RGT. KIT BL-204 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 27 | 00816426020979 | K114C-4M | K114C-4M | For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for lipoprotein(a) [Lp(a)]. | K-ASSAY® Lp(a) Control | KAMIYA BIOMEDICAL COMPANY, LLC |
| 28 | 00816426020962 | K114C-2M | K114C-2M | For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for lipoprotein(a) [Lp(a)]. | K-ASSAY® Lp(a) Control | KAMIYA BIOMEDICAL COMPANY, LLC |
| 29 | 00816426020245 | KAI-044 | KAI-044 | For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by i For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay. | K-ASSAY® Lp(a) Reagent | KAMIYA BIOMEDICAL COMPANY, LLC |
| 30 | 00816426020122 | KAI-017 | KAI-017 | For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by i For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay. | K-ASSAY® Lp(a) Reagent (L) | KAMIYA BIOMEDICAL COMPANY, LLC |
| 31 | 00813132020446 | 502-001AA | 502-001 | TorqMax™ Sheath Grip Assembly | TorqMax™ | SPECTRANETICS CORPORATION |
| 32 | 00811727016225 | 16-L7597-160 | 16-L7597-160 | Pointe Lp(a) Reagent packaged for use on the Mindray BA800. 2 x 60ml R1, 2 x 2 Pointe Lp(a) Reagent packaged for use on the Mindray BA800. 2 x 60ml R1, 2 x 20ml R2. The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples. The measurement of Lp(a) is useful in assessing lipid metabolism disorders and atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests. | Pointe Lp(a) Reagent | POINTE SCIENTIFIC, INC. |
| 33 | 00811727015921 | 14-L7597-216 | 14-L7597-216 | Pointe Lp(a) Reagent packaged for use on the Mindray BS480. 4 x 40ml R1, 4 x 14m Pointe Lp(a) Reagent packaged for use on the Mindray BS480. 4 x 40ml R1, 4 x 14ml R2. The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples. The measurement of Lp(a) is useful in assessing lipid metabolism disorders and atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests. | Pointe Lp(a) Reagent | POINTE SCIENTIFIC, INC. |
| 34 | 00811727011831 | L7597-CAL | L7597-CAL | Pointe Scientific, Inc. Lipoprotein (a) Calibrator Set for in vitro use only. T Pointe Scientific, Inc. Lipoprotein (a) Calibrator Set for in vitro use only. This five level calibrator set is intended for use in the quantitative determination of Lp(a) in human serum by immunoturbidimetric analysis. | Pointe Scientific, Inc. Lipoprotein (a) | POINTE SCIENTIFIC, INC. |
| 35 | 00811727011824 | L7597-40 | L7597-40 | Pointe Scientific, Inc. Lipoprotein (a) Reagent is an in vitro diagnostic test f Pointe Scientific, Inc. Lipoprotein (a) Reagent is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples.1 x 30 ml, 1 x 10 ml | Pointe Scientific, Inc. Lipoprotein (a) | POINTE SCIENTIFIC, INC. |
| 36 | 00630414595559 | 11097627 | 11097627 | Lipoprotein A (LP(a)) Atellica CH - RGT 400T | Atellica CH Lp(a) | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 37 | 00380740175146 | 9D93-22 | 09D9322 | Apolipoprotein B | ARCHITECT | ABBOTT GMBH |
| 38 | 00380740170165 | 09D9324 | 09D9324 | Apolipoprotein B 243 tests | ARCHITECT | ABBOTT IRELAND |
| 39 | 00380740170158 | 09P4724 | 09P4724 | Apolipoprotein B 190 Tests | Alinity | ABBOTT IRELAND |
| 40 | 00380740156435 | 07K0041 | 07K0041 | Quantia Lipoprotein(a) | ARCHITECT | ABBOTT LABORATORIES |
| 41 | 00380740154509 | 09P4720 | 09P4720 | Alinity c Apolipoprotein B Reagent Kit 190 Tests | Alinity | ABBOTT GMBH |
| 42 | 00380740153847 | 01R1421 | 01R1421 | Alinity c Lp(a) Reagent Kit 200 Tests | Alinity | ABBOTT LABORATORIES |
| 43 | 00380740054267 | 7K00-40 | 07K0040 | Quantia Lipoprotein(a) | ARCHITECT | ABBOTT LABORATORIES |
| 44 | 00380740019723 | 9D93-21 | 09D9321 | Apolipoprotein B | ARCHITECT | ABBOTT LABORATORIES |