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 | 07613336154366 | 04641655160 | 04641655160 | tPSA reagent, 100 Test-Kit | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
22 | 07613336154311 | 06427405160 | 06427405160 | Anti-HCV II 200-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
23 | 07613336154304 | 06368921160 | 06368921160 | Anti-HCV II 100-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
24 | 07613336153949 | 04927931161 | 04927931161 | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | PreciControl Anti-HBc II | |
25 | 07613336147672 | 08243875190 | 08243875190 | JIT | Calibrator, secondary | 2 | CalSet PTH | |
26 | 07613336141953 | 5920353001 | 5984840001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
27 | 07613336133644 | 08105596190 | 08105596190 | NDY | TEST, CYSTATIN C | 2 | Tina-quant Cystatin C Gen.2 | |
28 | 07613336133583 | 08105529190 | 08105529190 | JZG | System, test, beta-2-microglobulin immunological | 2 | Tinaquant ß2Microglobulin | |
29 | 07613336133521 | 08105448190 | 08105448190 | DER | ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Apolipoprotein A-1 ver.2 | |
30 | 07613336130230 | 08101396190 | 08101396190 | DEM | ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant a1-Antitrypsin ver.2 | |
31 | 07613336121429 | 08058024190 | 08058024190 | JIF | ENZYMATIC METHOD, AMMONIA | 1 | Ammonia II | |
32 | 07613336121351 | 08057940190 | 08057940190 | KHP | ACID, LACTIC, ENZYMATIC METHOD | 1 | Lactate Gen.2 | |
33 | 07613336121238 | 08057648190 | 08057648190 | DBF | FERRITIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Ferritin Gen.4 | |
34 | 07613336121108 | 08057435190 | 08057435190 | KLT | ENZYME IMMUNOASSAY, CARBAMAZEPINE | 2 | ONLINE TDM Carbamazepine Gen.4 | |
35 | 07613336121061 | 08056951190 | 08056951190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Bilirubin Direct Gen.2 | |
36 | 04015630999477 | 5133181160 | 5133181160 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Elecsys Anti-CCP CalCheck | |
37 | 04015630995318 | 11776827160 | 11776827160 | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | Elecsys CalCheck FSH | |
38 | 04015630999200 | 4357221190 | 4357221190 | DLJ | CALIBRATORS, DRUG SPECIFIC | 2 | Total MPA Calibrators | |
39 | 04015630999149 | 4924495190 | 4924495190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
40 | 04015630997954 | 4642465190 | 4642465190 | LEG | ENZYME IMMUNOASSAY, VALPROIC ACID | 2 | Valproic Acid ONLINE TDM Valproic Acid | |
41 | 04015630997756 | 4490894190 | 4490894190 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
42 | 04015630996575 | 3304680190 | 3304680190 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | Preciset DAT Plus II | |
43 | 04015630995202 | 11776614190 | 11776614190 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | AFP CalCheck | |
44 | 04015630994847 | 11815601216 | 11815601216 | LGI | FLUORESCENCE POLARIZATION IMMUNOASSAY, CARBAMAZEPINE | 2 | CEDIA Carbamazepine II | |
45 | 04015630994533 | 20766356122 | 20766356122 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | LSD CalibrationControl Pack | |
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 | 00630414982281 | 10708295 | LUPCM(D) | sPS Third Generation PSA Control Module | IMMULITE®Systems sPS CONTROL Third Generation PSA | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
2 | 00630414982267 | 10706293 | LK3PS1(D) | 3PS Third Generation PSA Kit 100 Test | IMMULITE®/IMMULITE®1000 Systems 3PS Third Generation PSA | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
3 | 00630414982229 | 10706282 | L2KPTS6(D) | PTS PSA Kit 600 Test | IMMULITE® 2000 Systems PTS PSA | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
4 | 00630414982212 | 10706281 | L2KPTS2(D) | PTS PSA Kit 200 Test | IMMULITE® 2000 Systems PTS PSA | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
5 | 00630414982205 | 10706279 | LKPTS1(D) | PTS PSA Kit 100 Test | IMMULITE®/IMMULITE®1000 Systems PTS PSA | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
6 | 00630414954196 | 10386994 | LPSZ | PSA Sample Diluent | IMMULITE®/IMMULITE®1000 Systems PSA PSA Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
7 | 00630414598451 | 10995518 | 10995518 | Calibrator Q - Atellica IM - CAL (6PK) 6 x 2 x 2 mL | Atellica IM Calibrator Q | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
8 | 00630414598444 | 10995517 | 10995517 | Calibrator Q Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL | Atellica IM Calibrator Q | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
9 | 00630414202938 | 10310295 | 118220 | Calibrator Q - 2 pack (PSA Cal) | ADVIA Centaur® Systems. ACS:180® Systems Calibrator Q | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
10 | 00630414202921 | 10310296 | 118221 | Calibrator Q - 6 pack (PSA Cal) | ADVIA Centaur® Systems, ACS:180® Systems Calibrator Q | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
11 | 00380740158323 | 07P9231 | 07P9231 | Alinity i Total PSA Reagent Kit 1200 Tests | Alinity | ABBOTT IRELAND DIAGNOSTICS |
12 | 00380740158316 | 07P9221 | 07P9221 | Alinity i Total PSA Reagent Kit 200 Tests | Alinity | ABBOTT IRELAND DIAGNOSTICS |
13 | 00380740130428 | 07P9210 | 07P9210 | Alinity i Total PSA Controls | Alinity | ABBOTT IRELAND DIAGNOSTICS |
14 | 00380740130411 | 07P9201 | 07P9201 | Alinity i Total PSA Calibrators | Alinity | ABBOTT IRELAND DIAGNOSTICS |
15 | 00380740008994 | 6C06-35 | 06C0635 | ARCHITECT Total PSA Reagent Kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
16 | 00380740008987 | 6C06-27 | 06C0627 | ARCHITECT Total PSA Reagent Kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
17 | 00380740008970 | 6C06-10 | 06C0610 | ARCHITECT Total PSA Controls | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
18 | 00380740008963 | 6C06-01 | 06C0601 | ARCHITECT Total PSA Calibrators | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
19 | 07613336167496 | 08838534160 | 08838534160 | total PSA CalSet II | ROCHE DIAGNOSTICS GMBH | |
20 | 07613336166000 | 08791716160 | 08791716160 | Elecsys total PSA | ROCHE DIAGNOSTICS GMBH | |
21 | 07613336165997 | 08791686160 | 08791686160 | Elecsys total PSA | ROCHE DIAGNOSTICS GMBH | |
22 | 07613336165980 | 08791732190 | 08791732190 | Elecsys total PSA | ROCHE DIAGNOSTICS GMBH | |
23 | 07613336154380 | 04485220160 | 04485220160 | Total PSA G2 CS Elecsys V2.1 | total PSA Calset II | ROCHE DIAGNOSTICS GMBH |
24 | 07613336154373 | 04491734160 | 04491734160 | tPSA reagent 200 | Elecsys tPSA | ROCHE DIAGNOSTICS GMBH |
25 | 07613336154366 | 04641655160 | 04641655160 | tPSA reagent, 100 Test-Kit | Elecsys tPSA | ROCHE DIAGNOSTICS GMBH |
26 | H628372061 | 37206 | 37206 | The Access Hybritech PSA Sample Diluent is intended for use with the Access Hybr The Access Hybritech PSA Sample Diluent is intended for use with the Access Hybritech PSA assay to dilute patient samples containing total prostate specific antigen (PSA) concentrations greater than the S5 calibrator. | Access Hybritech PSA Sample Diluent | BECKMAN COULTER, INC. |
27 | H628372051 | 37205 | 37205 | The Access Hybritech PSA Calibrators are intended to calibrate the Access Hybrit The Access Hybritech PSA Calibrators are intended to calibrate the Access Hybritech PSA assay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. | Access Hybritech PSA Calibrators | BECKMAN COULTER, INC. |
28 | H628372001 | 37200 | 37200 | The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immu The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer. | Access Hybritech PSA | BECKMAN COULTER, INC. |
29 | 04015630939824 | 07027966190 | 07027966190 | Elecsys total PSA | ROCHE DIAGNOSTICS GMBH | |
30 | 04015630921515 | 04641655160 | 04641655160 | Elecsys Total PSA Immunoassay | ROCHE DIAGNOSTICS GMBH | |
31 | 04015630920877 | 04491734160 | 04491734160 | Elecsys Total PSA Immunoassay | ROCHE DIAGNOSTICS GMBH | |
32 | 04015630920754 | 04485220160 | 04485220160 | Elecsys Total PSA CalSet II | ROCHE DIAGNOSTICS GMBH | |
33 | 03573026156985 | TPSA | 30428-01 | VIDAS® TPSA is a In Vitro Diagnostic kit for the quantitative detection of total VIDAS® TPSA is a In Vitro Diagnostic kit for the quantitative detection of total prostate specific antigen (PSA) in human serum, using an enzyme immunoassay (EIA) method. | VIDAS® | BIOMERIEUX SA |
34 | 00842768016660 | 10445090 | K6451 | Total Prostate Specific Antigen Flex® reagent cartridge 120 Test | Dimension Vista® System TPSA Flex® Reagent Cartridge | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
35 | 00842768013874 | 10444889 | RF451 | Heterogeneous Immunoassay Module Total Prostate Specific Antigen Flex® reagent c Heterogeneous Immunoassay Module Total Prostate Specific Antigen Flex® reagent cartridge 120 Test | Dimension® clinical chemistry system TPSA Flex® reagent cartridge | SIEMENS HEALTHCARE DIAGNOSTICS INC. |