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 | 04015630940356 | 07251378190 | 07251378190 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH | |
2 | 04015630934881 | 06923348190 | 06923348190 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH | |
3 | 03610522015597 | 12007240 | 12007240 | U.S. IFU (United States) Manual & CDs, BioPlex 2200 Syphilis Total & RPR IFU 4.3v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
4 | 03610522004980 | 12006863 | 12006863 | BioPlex 2200 Sample Dilution Buffer (1X), 120 mL | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
5 | 03610520992692 | 4.3 | 12000656 | U.S. IFU, Manual & CDs, BioPlex 2200 Syphilis Total & RPR SW4.3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
6 | 03610520653012 | 12000650 | 12000650 | BioPlex 2200 Syphilis Total & RPR Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
7 | 03610520138267 | 4.3_v1 | 12000657 | BioPlex 2200 Syphilis Total & RPR Assay Protocol File CD SW4.3_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
8 | 00868926000302 | B012 | Syphilis Health Check | VEDALAB | ||
9 | 00850487007609 | Syphilis G | Q01-580 | Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
10 | 00850487007043 | Syphilis G | Q01-580 | Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
11 | 00847865010924 | SW4.1_v1 | 6651470E | Syphilis IgG Assay Protocol File CD, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
12 | 00847865006682 | SW4.1_V1 | 6651460F | Manual & CDs, Syphilis IgG IFU, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
13 | 00847865002233 | SW4_V2 | 6651470D | Syphilis IgG Assay Protocol File CD, SW4_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
14 | 00847865002134 | SW4_V2 | 6651460E | Manual & CDs, BioPlex 2200, Syphilis IgG IFU, SW4_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
15 | 00847865000307 | 6651450 | 6651450 | Syphilis IgG Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
16 | 00630414976891 | 10471981 | L2KSY2(D) | Syphilis - IMMULITE - RGT - 200 tests | IMMULITE® 2000 Systems SYP Syphilis Screen | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
17 | 00630414976709 | 10469595 | LCVGCM | CMV IgG - IMMULITE - CTL | IMMULITE® Systems CVG CONTROL CMV IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
18 | 00630414976686 | 10469593 | LSYCM | Syphillis - IMMULITE - CTL - 2x6mL | IMMULITE® Systems SYP CONTROL Syphilis Screen | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
19 | 00630414599892 | 10995676 | 10995676 | Syphillis (Syph) QC Kit Atellica IM - CLT 2 x 2 x 7.0mL | Atellica IM Syph QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
20 | 00630414599885 | 10995675 | 10995675 | Syphillis (Syph) Atellica IM - RGT 200T | Atellica IM Syph | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
21 | 00630414580173 | 10492493 | 10492493 | Syphilis - CENTAUR - RGT - 200 tests | ADVIA Centaur® SYPH | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
22 | 00607158000083 | 65-9502-0 | The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2), and/or Treponema pallidum bacteria (the causative agent of syphilis) in fingerstick whole blood, potassium-EDTA venous whole blood or potassium-EDTA plasma specimens. The test is intended to be used with the DPP Micro Reader. The test is intended for use by trained professionals in point of care and laboratory settings to aid in the diagnosis of HIV and syphilis infection. | DPP HIV-Syphilis | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
23 | 00380740138332 | 07P6031 | 07P6031 | Alinity i Syphilis TP Reagent Kit 1200 Tests | Alinity | ABBOTT GMBH |
24 | 00380740138196 | 07P6021 | 07P6021 | Alinity i Syphilis TP Reagent Kit 200 Tests | Alinity | ABBOTT GMBH |
25 | 00380740117122 | 8D06-41 | 08D0641 | ARCHITECT Syphilis TP Reagent Kit | ARCHITECT | ABBOTT GMBH |
26 | 00380740117115 | 8D06-31 | 08D0631 | ARCHITECT Syphilis TP Reagent Kit | ARCHITECT | ABBOTT GMBH |
27 | 00380740103545 | 8D06-13 | 08D0613 | ARCHITECT Syphilis TP Controls | ARCHITECT | ABBOTT GMBH |
28 | 00380740103538 | 8D06-04 | 08D0604 | ARCHITECT Syphilis TP Calibrator | ARCHITECT | ABBOTT GMBH |
29 | 07613336171998 | 09015051190 | 09015051190 | Syphilis Elecsys E2G 300 V2 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH |
30 | 07613336171950 | 09014977190 | 09014977190 | Syphilis Elecsys cobas e 100 V2 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH |
31 | 05391516748766 | 1206711 | 1206711 | Uni-Gold™ Syphilis Treponemal Control, Syphilis Treponemal Positive and Negative Uni-Gold™ Syphilis Treponemal Control, Syphilis Treponemal Positive and Negative Control, 1 Positive Control and 1 Negative Control | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
32 | 05391516748759 | 1206710 | 1206710 | Uni-Gold™ Syphilis Treponemal, 20 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
33 | 05391516747462 | TS-96-E | TS-96-E | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
34 | 05391516747448 | TS-960-E | TS-960-E | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
35 | 05391516747431 | TS-960 | TS-960 | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
36 | 05391516747424 | TS-96-Bulk | Trep Sure Bulk Kit | Phoenix Biotech | CLARK LABORATORIES, INC. | |
37 | 05391516747417 | TS-96 | TS-96 | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
38 | 05391516747400 | TS-1920 | TS-1920 | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
39 | 05391516747226 | 916401 | Stop Solution | Trinity Biotech | CLARK LABORATORIES, INC. | |
40 | 05391516746915 | 386470 | 386470 | Trep-Sure Conjugate | Phoenix Biotech | CLARK LABORATORIES, INC. |
41 | 05391516746908 | 829322 | Wash Buffer Concentrate 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
42 | 05391516746892 | 828882 | Trep-Sure Wash Buffer Concentrate, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
43 | 05391516746861 | 827882 | Trep-Sure Wash Buffer Concentrate, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
44 | 05391516746847 | 525777 | 525777 | Trep-Sure Substrate | Phoenix Biotech | CLARK LABORATORIES, INC. |
45 | 05391516746694 | 72520 | 72520 | Syphilis IgM EIA | BIO-RAD | CLARK LABORATORIES, INC. |
46 | 05391516746687 | 72517 | 72517 | Wash Solution, x20 (Non US Sales Only) | Bio-Rad | CLARK LABORATORIES, INC. |
47 | 05391516746588 | YY60126 | Syphilis EIA (Non-US sales only) | Bio-Stat | CLARK LABORATORIES, INC. | |
48 | 05391516745109 | 2322171 | 2322171 | CAPTIA™ Syphilis TA EIA | Trinity Biotech | CLARK LABORATORIES, INC. |
49 | 05391516745093 | 2322170 | 2322170 | CAPTIA™ Syphilis TA EIA | Trinity Biotech | CLARK LABORATORIES, INC. |
50 | 05391516745048 | 2329360 | 2329360 | CAPTIA™ NMT Syphilis IgM | Trinity Biotech | CLARK LABORATORIES, INC. |