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 | 00884883011571 | 1594 | DRI Multi-Drug Urine Calibrator 3 | MICROGENICS CORPORATION | ||
2 | 00884883011557 | 1815326 | CEDIA Multi-Drug Calibrator Primary Cutoffs | MICROGENICS CORPORATION | ||
3 | 00884883011502 | 1597 | DRI Multi-Drug Urine Calibrator 4 | MICROGENICS CORPORATION | ||
4 | 00884883011489 | 1557416 | CEDIA Negative Calibrator | MICROGENICS CORPORATION | ||
5 | 00884883011458 | 1588 | DRI Multi-Drug Urine Calibrator 1 | MICROGENICS CORPORATION | ||
6 | 00884883011045 | 10014954 | CEDIA Multi-Drug OFT Negative Calibrator | MICROGENICS CORPORATION | ||
7 | 00884883011038 | 10014955 | CEDIA Multi-Drug OFT Cutoff Calibrator | MICROGENICS CORPORATION | ||
8 | 00884883010987 | 10014957 | CEDIA Multi-Drug OFT Control Set | MICROGENICS CORPORATION | ||
9 | 00884883007116 | 08777934 190 | CEDIA Antibiotic TDM Multi-Cal | MICROGENICS CORPORATION | ||
10 | 00884883005969 | 1388 | DRI Negative Urine Calibrator | MICROGENICS CORPORATION | ||
11 | 00884883005914 | 100033 | CEDIA Multi-Drug Optional Cutoff Calibrator | MICROGENICS CORPORATION | ||
12 | 00884883005235 | 1598 | DRI Multi-Drug Urine Calibrator 4 | MICROGENICS CORPORATION | ||
13 | 00884883005228 | 1595 | DRI Multi-Drug Urine Calibrator 3 | MICROGENICS CORPORATION | ||
14 | 00884883005211 | 1592 | DRI Multi-Drug Urine Calibrator 2 | MICROGENICS CORPORATION | ||
15 | 00884883005143 | 1589 | DRI Multi-Drug Urine Calibrator 1 | MICROGENICS CORPORATION | ||
16 | 00884883005044 | 0036 | DRI Drugs of Abuse High Calibrator | MICROGENICS CORPORATION | ||
17 | 00884883004825 | 1815334 | CEDIA Multi-Drug Calibrator Primary Cutoffs | MICROGENICS CORPORATION | ||
18 | 00884883002647 | 1591 | DRI Multi-Drug Urine Calibrator 2 | MICROGENICS CORPORATION | ||
19 | 00884883002531 | 0034 | DRI Drugs of Abuse Low Calibrator | MICROGENICS CORPORATION | ||
20 | 00884883002067 | 1732226 | CEDIA Multi-Drug High Calibrator | MICROGENICS CORPORATION | ||
21 | 00884883002050 | 1732218 | CEDIA Multi-Drug Intermediate Calibrator | MICROGENICS CORPORATION | ||
22 | 00884883002043 | 1730517 | CEDIA Multi-Drug Calibrator Secondary Cutoffs | MICROGENICS CORPORATION | ||
23 | 00884883002036 | 1730428 | CEDIA Multi-Drug Calibrator Secondary Cutoffs | MICROGENICS CORPORATION | ||
24 | 00884883002029 | 1730401 | CEDIA Multi-Drug Calibrator Clinical Cutoffs | MICROGENICS CORPORATION | ||
25 | 00884883002012 | 1730398 | CEDIA Multi-Drug High Calibrator | MICROGENICS CORPORATION | ||
26 | 00884883002005 | 1730380 | CEDIA Multi-Drug Intermediate Calibrator | MICROGENICS CORPORATION | ||
27 | 00884883001961 | 1661388 | CEDIA Negative Calibrator | MICROGENICS CORPORATION | ||
28 | 00884883001329 | 100017 | CEDIA AntibioticTDM Multi-Calibrator | MICROGENICS CORPORATION | ||
29 | 00884883001251 | 100006 | CEDIA Carbamazepine II Assay | MICROGENICS CORPORATION | ||
30 | 00884883001190 | 1664 | DRI Negative Urine Calibrator | MICROGENICS CORPORATION | ||
31 | 00884883001138 | 0976 | DRI Serum Tox Calibrator 4 | MICROGENICS CORPORATION | ||
32 | 00884883001121 | 0967 | DRI Serum Tox Calibrator 3 | MICROGENICS CORPORATION | ||
33 | 00884883001114 | 0965 | DRI Serum Tox Calibrator 2 | MICROGENICS CORPORATION | ||
34 | 00884883001107 | 0963 | DRI Serum Tox Calibrator 1 | MICROGENICS CORPORATION | ||
35 | 00884883001091 | 0962 | DRI Serum Tox Negative Calibrator | MICROGENICS CORPORATION | ||
36 | 00859110005050 | 301vt | 301vt | Validate TDM1vt is intended for the quantitative determination of Calibration Ve Validate TDM1vt is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
37 | 00859110005043 | 301ri | 301ri | Validate TDM1ri is intended for the quantitative determination of Calibration Ve Validate TDM1ri is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
38 | 00859110005036 | 301db | 301db | Validate TDM1db is intended for the quantitative determination of Calibration Ve Validate TDM1db is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
39 | 00859110005029 | 301bc | 301bc | Validate TDM1bc is intended for the quantitative determination of Calibration Ve Validate TDM1bc is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
40 | 00859110005012 | 301au | 301au | Validate TDM1au is intended for the quantitative determination of Calibration Ve Validate TDM1au is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
41 | 00859110005005 | 301ab | 301ab | Validate TDM1ab is intended for the quantitative determination of Calibration Ve Validate TDM1ab is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
42 | 00842768034169 | 10470444 | 9R589UL | Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 4 | Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
43 | 00842768034152 | 10470443 | 9R569UL | Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 3 | Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 3 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
44 | 00842768034145 | 10470442 | 9R549UL | Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 2 | Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 2 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
45 | 00842768034138 | 10470441 | 9R529UL | Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1 | Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
46 | 00842768023231 | 10445311 | 4F229 | Emit® 2000 Carbamazepine Assay labeled with the Beckman Coulter® name | Emit® 2000 Carbamazepine Assay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
47 | 00842768016455 | 10445187 | KC510 | Drugs of Abuse Calibrator, 4x2.5mL / 2x2.6mL | Dimension Vista® UDAT CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
48 | 00842768015779 | 10445184 | KC420 | Drug 2 Calibrator, 3x2x2.5mL | Dimension Vista® DRUG 2 CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
49 | 00842768015137 | 10445129 | K4087 | Carbamazepine Flex® reagent cartridgem, 80 tests | Dimension Vista® Flex® reagent cartridge CRBM | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
50 | 00842768014352 | 10445423 | 9D039UL | Syva® Emit® II Plus Barbiturate Assay - 28 mL Kit | Syva® Emit® II Plus Barbiturate Assay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |