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 | 04015630993468 | 20737976122 | 20737976122 | DIS | ENZYME IMMUNOASSAY, BARBITURATE | 2 | Abuscreen OnLine Barbiturates | |
47 | 04015630993284 | 11986082216 | 11986082216 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
48 | 04015630991853 | 11876899216 | 11876899216 | CFR | HEXOKINASE, GLUCOSE | 2 | Glucoquant GlucoseHK | |
49 | 04015630991778 | 11868152190 | 11868152190 | DML | NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD | 2 | Ethyl Alcohol ETH | |
50 | 04015630991761 | 11776312190 | 11776312190 | 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 | 05060500092023 | IR952-DAU | IR952-DAU | Multi-Analyte DAU Calibrator Kit 4 X 15 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
2 | 05060500091651 | 0855 | 0855 | Drugs of Abuse High Calibrator 1 X 15 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
3 | 05060500091644 | 0854 | 0854 | Drugs of Abuse Intermediate Calibrator 1 X 15 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
4 | 05060500091637 | 0853 | 0853 | Drugs of Abuse Cutoff Calibrator 1 X 15 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
5 | 05060500091620 | 0852 | 0852 | Drugs of Abuse Low Calibrator 1 X 15 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
6 | 05060500091613 | 001 | 001 | Drugs of Abuse Negative Calibrator 1 X 15 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
7 | 05055273207880 | DA2704 | DA2704 | The Randox Multidrug Calibrator Set is intended for use in the calibration of Me The Randox Multidrug Calibrator Set is intended for use in the calibration of Methamphetamine, Barbiturates, Cocaine Metabolite, Methadone and Opiate assays. | DOA CAL | RANDOX LABORATORIES LIMITED |
8 | 05055273207866 | DA2702 | DA2702 | The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-e The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. | EDDP CAL | RANDOX LABORATORIES LIMITED |
9 | 05055273206470 | TD3417 | TD3417 | This product is intended for use in the calibration of therapeutic drug assays. | TDM CAL | RANDOX LABORATORIES LIMITED |
10 | 05055273202458 | EV3550 | EV3550 | Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser. | DOA CAL | RANDOX LABORATORIES LIMITED |
11 | 04015630996971 | 3375781190 | 3375781190 | Preciset TDM II | ROCHE DIAGNOSTICS GMBH | |
12 | 04015630996964 | 3375790190 | 3375790190 | Preciset TDM I | ROCHE DIAGNOSTICS GMBH | |
13 | 04015630996582 | 3304698190 | 3304698190 | Cfas DAT Qualitiative Plus | ROCHE DIAGNOSTICS GMBH | |
14 | 04015630996575 | 3304680190 | 3304680190 | Preciset DAT Plus II | ROCHE DIAGNOSTICS GMBH | |
15 | 04015630996568 | 3304671190 | 3304671190 | Preciset DAT Plus I | ROCHE DIAGNOSTICS GMBH | |
16 | 04015630995172 | 11815253216 | 11815253216 | CEDIA Core TDM MultiCal | ROCHE DIAGNOSTICS GMBH | |
17 | 04015630995158 | 11815245216 | 11815245216 | CEDIA Antibiotic TDM Multi-Cal | ROCHE DIAGNOSTICS GMBH | |
18 | 04015630994533 | 20766356122 | 20766356122 | LSD CalibrationControl Pack | ROCHE DIAGNOSTICS GMBH | |
19 | 04015630935048 | 7007515190 | 7007515190 | ACET2 calibrator | ROCHE DIAGNOSTICS GMBH | |
20 | 00884883011571 | 1594 | DRI Multi-Drug Urine Calibrator 3 | MICROGENICS CORPORATION | ||
21 | 00884883011557 | 1815326 | CEDIA Multi-Drug Calibrator Primary Cutoffs | MICROGENICS CORPORATION | ||
22 | 00884883011502 | 1597 | DRI Multi-Drug Urine Calibrator 4 | MICROGENICS CORPORATION | ||
23 | 00884883011489 | 1557416 | CEDIA Negative Calibrator | MICROGENICS CORPORATION | ||
24 | 00884883011458 | 1588 | DRI Multi-Drug Urine Calibrator 1 | MICROGENICS CORPORATION | ||
25 | 00884883011045 | 10014954 | CEDIA Multi-Drug OFT Negative Calibrator | MICROGENICS CORPORATION | ||
26 | 00884883011038 | 10014955 | CEDIA Multi-Drug OFT Cutoff Calibrator | MICROGENICS CORPORATION | ||
27 | 00884883010987 | 10014957 | CEDIA Multi-Drug OFT Control Set | MICROGENICS CORPORATION | ||
28 | 00884883007116 | 08777934 190 | CEDIA Antibiotic TDM Multi-Cal | MICROGENICS CORPORATION | ||
29 | 00884883005969 | 1388 | DRI Negative Urine Calibrator | MICROGENICS CORPORATION | ||
30 | 00884883005914 | 100033 | CEDIA Multi-Drug Optional Cutoff Calibrator | MICROGENICS CORPORATION | ||
31 | 00884883005235 | 1598 | DRI Multi-Drug Urine Calibrator 4 | MICROGENICS CORPORATION | ||
32 | 00884883005228 | 1595 | DRI Multi-Drug Urine Calibrator 3 | MICROGENICS CORPORATION | ||
33 | 00884883005211 | 1592 | DRI Multi-Drug Urine Calibrator 2 | MICROGENICS CORPORATION | ||
34 | 00884883005143 | 1589 | DRI Multi-Drug Urine Calibrator 1 | MICROGENICS CORPORATION | ||
35 | 00884883005044 | 0036 | DRI Drugs of Abuse High Calibrator | MICROGENICS CORPORATION | ||
36 | 00884883004825 | 1815334 | CEDIA Multi-Drug Calibrator Primary Cutoffs | MICROGENICS CORPORATION | ||
37 | 00884883002647 | 1591 | DRI Multi-Drug Urine Calibrator 2 | MICROGENICS CORPORATION | ||
38 | 00884883002531 | 0034 | DRI Drugs of Abuse Low Calibrator | MICROGENICS CORPORATION | ||
39 | 00884883002067 | 1732226 | CEDIA Multi-Drug High Calibrator | MICROGENICS CORPORATION | ||
40 | 00884883002050 | 1732218 | CEDIA Multi-Drug Intermediate Calibrator | MICROGENICS CORPORATION | ||
41 | 00884883002043 | 1730517 | CEDIA Multi-Drug Calibrator Secondary Cutoffs | MICROGENICS CORPORATION | ||
42 | 00884883002036 | 1730428 | CEDIA Multi-Drug Calibrator Secondary Cutoffs | MICROGENICS CORPORATION | ||
43 | 00884883002029 | 1730401 | CEDIA Multi-Drug Calibrator Clinical Cutoffs | MICROGENICS CORPORATION | ||
44 | 00884883002012 | 1730398 | CEDIA Multi-Drug High Calibrator | MICROGENICS CORPORATION | ||
45 | 00884883002005 | 1730380 | CEDIA Multi-Drug Intermediate Calibrator | MICROGENICS CORPORATION | ||
46 | 00884883001961 | 1661388 | CEDIA Negative Calibrator | MICROGENICS CORPORATION | ||
47 | 00884883001329 | 100017 | CEDIA AntibioticTDM Multi-Calibrator | MICROGENICS CORPORATION | ||
48 | 00884883001190 | 1664 | DRI Negative Urine Calibrator | MICROGENICS CORPORATION | ||
49 | 00884883001138 | 0976 | DRI Serum Tox Calibrator 4 | MICROGENICS CORPORATION | ||
50 | 00884883001121 | 0967 | DRI Serum Tox Calibrator 3 | MICROGENICS CORPORATION |