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 | 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 | 00884883001190 | 1664 | DRI Negative Urine Calibrator | MICROGENICS CORPORATION | ||
30 | 00884883001138 | 0976 | DRI Serum Tox Calibrator 4 | MICROGENICS CORPORATION | ||
31 | 00884883001121 | 0967 | DRI Serum Tox Calibrator 3 | MICROGENICS CORPORATION | ||
32 | 00884883001114 | 0965 | DRI Serum Tox Calibrator 2 | MICROGENICS CORPORATION | ||
33 | 00884883001107 | 0963 | DRI Serum Tox Calibrator 1 | MICROGENICS CORPORATION | ||
34 | 00884883001091 | 0962 | DRI Serum Tox Negative Calibrator | MICROGENICS CORPORATION | ||
35 | 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. |
36 | 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. |
37 | 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. |
38 | 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. |
39 | 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. |
40 | 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. |
41 | 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. |
42 | 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. |
43 | 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. |
44 | 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. |
45 | 00842768016455 | 10445187 | KC510 | Drugs of Abuse Calibrator, 4x2.5mL / 2x2.6mL | Dimension Vista® UDAT CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
46 | 00842768015779 | 10445184 | KC420 | Drug 2 Calibrator, 3x2x2.5mL | Dimension Vista® DRUG 2 CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
47 | 00842768005176 | 10445005 | DC49D | Drug Calibrator II, 2x5x5mL | Dimension® DRUG Calibrator II | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
48 | 00842768002007 | 10445449 | 9K079UL | Syva® Emit® Ethyl Alcohol High Control | Syva® Emit® Ethyl Alcohol High Control | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
49 | 00842768001994 | 10445448 | 9K059UL | Syva® Emit ® Ethyl Alcohol 100 mg/dL Calibrator | Syva® Emit® Ethyl Alcohol 100 mg/dL Calibrator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
50 | 00842768001987 | 10445447 | 9K049UL | Syva® Emit® Ethyl Alcohol Low Control | Syva® Emit® Ethyl Alcohol Low Control | SIEMENS HEALTHCARE DIAGNOSTICS INC. |