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 | 00816057020522 | NC-800096-AM | NC-800096-AM | Detection of Rubella Virus Antibody | ASI Rubella IgM EIA Test | ARLINGTON SCIENTIFIC, INC. |
2 | 00816057020515 | NC-800096-AG | NC-800096-AG | Detection of Rubella Virus Antiboby | ASI Rubella IgG EIA Test | ARLINGTON SCIENTIFIC, INC. |
3 | 00811727015181 | T8004-96 | T8004-96 | Pointe Scientific, Inc. Rubella IgM is for the qualitative detection of human Ig Pointe Scientific, Inc. Rubella IgM is for the qualitative detection of human IgM antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the diagnosis of rubella infection. A positive result is presumptive for the detection of anti-rubella IgM antibodies and presumptive for the diagnosis of acute or recent rubella infection. 96 tests | Pointe Scientific, Inc. Rubella IgM | POINTE SCIENTIFIC, INC. |
4 | 00811727015174 | T8003-96 | T8003-96 | Pointe Scientific, Inc. Rubella IgG is for the qualitative, semi-quantitative an Pointe Scientific, Inc. Rubella IgG is for the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests | Pointe Scientific, Inc. Rubella IgG | POINTE SCIENTIFIC, INC. |
5 | 00630414976730 | 10469599 | LRUBCM | Rubella IGG - IMMULITE - CTL | IMMULITE® Systems RUB CONTROL Rubella IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
6 | 00630414976716 | 10469597 | LRMCM | Rubella IGM - IMMULITE - CTL | IMMULITE® Systems RUM CONTROL Rubella IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
7 | 00630414971582 | 10374044 | LKRM1(D) | IMMULITE®/IMMULITE® 1000 Systems Rubella IgM | IMMULITE®/IMMULITE® 1000 Systems Rubella IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
8 | 00630414971469 | 10374021 | L2KRM2(D) | Rubella IgM Ab - IMMULITE - RGT - 200 tests | IMMULITE® 2000 Systems RUM Rubella IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
9 | 00630414964614 | 10381292 | LKRUB1 | Rubella IgG Ab - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
10 | 00630414962061 | 10381305 | L2KRUB6 | Rubella IgG Ab - IMMULITE - RGT - 600 Tests | IMMULITE® 2000 Systems RUB Rubella Quantitative IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
11 | 00630414962054 | 10381338 | L2KRUB2 | Rubella IgG Ab - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems RUB Rubella Quantitative IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
12 | 00630414600536 | 10995671 | 10995671 | Rubella IgG (Rub G) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL | Atellica IM Rub G QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
13 | 00630414600529 | 10995670 | 10995670 | Rubella IgG (Rub G) Atellica IM - RGT 100T | Atellica IM Rub G | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
14 | 00630414599847 | 10995669 | 10995669 | Rubella IgM (Rub M) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL | Atellica IM Rub M QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
15 | 00630414599830 | 10995668 | 10995668 | Rubella IgM (Rub M) Atellica IM - RGT 50T | Atellica IM Rub M | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
16 | 00630414201443 | 10310286 | 117734 | Rubella IgM - CENTAUR - CONS - 2x2x2,7mL | ADVIA Centaur® Rub M QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
17 | 00630414201436 | 10310285 | 117733 | Rubella IgM Ab - CENTAUR - RGT - 50 tests | ADVIA Centaur® Rub M | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
18 | 00630414201429 | 10310284 | 117711 | Rubella IgG - CENTAUR - CONS - 3x2x2,7mL | ADVIA Centaur® Rub G QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
19 | 00630414201412 | 10310283 | 117710 | Rubella IgG Ab - CENTAUR - RGT - 100 tests | ADVIA Centaur® Rub G | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
20 | B3507203600 | 720-360 | 720-360 | ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-qu ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-quantitative detection of IgG antibodies to rubella in human serum to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child bearing age. | Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
21 | 15099590624897 | 34430 | 34430 | The Access Rubella IgG assay is a paramagnetic particle, chemiluminescent immuno The Access Rubella IgG assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems. | Access Rubella IgG | BECKMAN COULTER, INC. |
22 | 15099590624880 | 33435 | 34435 | The Access Rubella IgG Calibrators are intended to calibrate the Access Rubella The Access Rubella IgG Calibrators are intended to calibrate the Access Rubella IgG assay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems. | Access Rubella IgG Calibrators | BECKMAN COULTER, INC. |
23 | 15099590624873 | 34439 | 34439 | The Access Rubella IgG QC is intended for monitoring the system performance of t The Access Rubella IgG QC is intended for monitoring the system performance of the Access Rubella IgG assay. | Access Rubella IgG QC | BECKMAN COULTER, INC. |
24 | 10859035006245 | 84R2 | Alere Rubella-plus® | ALERE NORTH AMERICA, LLC | ||
25 | 10758750004997 | 8536195 | 8536195 | VITROS Immunodiagnostic Products Rubella IgG Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
26 | 10758750004546 | 8209074 | 8209074 | VITROS Immunodiagnostic Products Rubella IgG Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
27 | 10743816001034 | BSP-171-10-01 | BSP-171-10-01 | BioSign® Rubella card; 10 Test kit; CE | BioSign® Rubella card | PRINCETON BIOMEDITECH CORPORATION |
28 | 10743816001027 | BSP-171-35-01 | BSP-171-35-01 | BioSign® Rubella card; 35 Test kit; CE | BioSign® Rubella card | PRINCETON BIOMEDITECH CORPORATION |
29 | 05391516747011 | 2325361 | 2325361 | Captia™ Rubella IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
30 | 05391516747004 | 2325301 | 2325301 | Captia™ Rubella IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
31 | 05391516746878 | 828102 | Wash Buffer Concentrate Type I, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
32 | 05391516746786 | 617134 | Serum Diluent Type I | Trinity Biotech | CLARK LABORATORIES, INC. | |
33 | 05391516746748 | 616134 | Serum Diluent Type I | Trinity Biotech | CLARK LABORATORIES, INC. | |
34 | 05391516746533 | 525700 | Substrate Solution (TMB) | Trinity Biotech | CLARK LABORATORIES, INC. | |
35 | 05391516746526 | 915401 | Stop Solution | Trinity Biotech | CLARK LABORATORIES, INC. | |
36 | 05391516746519 | 827102 | Wash Buffer Concentrate Type I, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
37 | 05391516743457 | 2325360 | 2325360 | Captia™ Rubella IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
38 | 05391516743440 | 2325350 | 2325350 | Captia™ Rubella IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
39 | 05391516743433 | 2325300 | 2325300 | Captia™ Rubella IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
40 | 04015630940257 | 07027796190 | 07027796190 | Elecsys Rubella IgM | ROCHE DIAGNOSTICS GMBH | |
41 | 04015630940240 | 07027770190 | 07027770190 | Elecsys Rubella IgG | ROCHE DIAGNOSTICS GMBH | |
42 | 04015630939275 | 4618831160 | 4618831160 | Elecsys Rubella IgM Immunoassay | ROCHE DIAGNOSTICS GMBH | |
43 | 04015630939251 | 4618793160 | 4618793160 | Elecsys Rubella IgG Immunoassay | ROCHE DIAGNOSTICS GMBH | |
44 | 03573026138585 | 30226 | VIDAS ® RUB IgG (RBG) assay is a quantitative IA intended for use on VIDAS fami VIDAS ® RUB IgG (RBG) assay is a quantitative IA intended for use on VIDAS family instrument in the determination of IgG antibodies to rubella virus in human serum. | VIDAS® RUB IgG | BIOMERIEUX SA | |
45 | 00850487007395 | RUB M | Q01-110 | Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
46 | 00850487007388 | RUB G | Q01-100 | Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
47 | 00850487007074 | RUB G | Q01-100 | Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
48 | 00850487007067 | RUB M | Q01-110 | Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
49 | 00847865012577 | SW4.1_V1 | 6653860D | Manual & CDs, Rubella & CMV IgM IFU, SW4.1_v1, U.S Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
50 | 00847865011006 | SW4.1_V1 | 6653870D | Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |