No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00630414998947 | 10285226 | LSHCM | SHBG - IMMULITE - CTL - 1x1x2mL | CDZ | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE | 1 | IMMULITE® SBG Control SHBG |
2 | 00630414995939 | 10386016 | M15L2 | Trichoderma viride -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Trichoderma viride |
3 | 00630414995922 | 10386017 | M16L2 | Curvularia lunata -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Curvularia lunata |
4 | 00630414995823 | 10386113 | T96L2 | Poplar-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Poplar |
5 | 00630414989907 | 10469596 | LHPGCM | H.Pylori - IMMULITE - CTL | LYR | Helicobacter pylori | 1 | IMMULITE® Systems HPG CONTROL H.pylori IgG |
6 | 00630414988122 | 10368597 | A89L2 | Native Bet v 1-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ nBet v 1 |
7 | 00630414986081 | 10642238 | LSKTI1(D) | MMI | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | IMMULITE®/IMMULITE® 1000 Systems RTI Turbo Troponin I | |
8 | 00630414984599 | 10485107 | L2SNCCM | Specific IgE Neg - IMMULITE - CTL - 1x4mL | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE® Systems neg CONTROL 3gAllergy™ Specific IgE Negative Control |
9 | 00630414984575 | 10485105 | DC2LCM | Specific IgE D2 - IMMULITE - CTL - 1x4mL | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE Systems 3gAllergy Specific IgE Positive Control for D2 |
10 | 00630414984452 | 10381168 | LKUE31 | Estriol unconjugated - IMMULITE - RGT - 100 Tests | CGI | RADIOIMMUNOASSAY, ESTRIOL | 1 | IMMULITE®/IMMULITE® 1000 Systems UE3 Unconjugated Estriol |
11 | 00630414979182 | 10386153 | W37L2 | Saltbush-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Saltbush |
12 | 00630414979113 | 10386135 | W14L2 | Rough Pigweed -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Rough Pigweed |
13 | 00630414979021 | 10386092 | T41L2 | White Hickory-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ White Hickory |
14 | 00630414978994 | 10386088 | T401L2 | Brazilian Peppertree-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Brazilian Peppertree |
15 | 00630414978987 | 10386085 | T37L2 | White Bald Cypress-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ White Bald Cypress |
16 | 00630414978895 | 10386050 | O201L2 | Tobacco-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tabacco |
17 | 00630414978611 | 10385835 | F50L2 | Chub Mackerel-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Chub Makerel |
18 | 00630414978543 | 10385755 | F261L2 | Asparagus-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Asparagus |
19 | 00630414977478 | 10487239 | L2KPF2(D) | fPS Free PSA Kit 200 Test | MTG | Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cance Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | 3 | IMMULITE® 2000 Systems fPS Free PSA |
20 | 00630414976686 | 10469593 | LSYCM | Syphillis - IMMULITE - CTL - 2x6mL | LIP | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM | 2 | IMMULITE® Systems SYP CONTROL Syphilis Screen |
21 | 00630414973548 | 10386060 | T15L2 | White Ash -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ White Ash |
22 | 00630414973326 | 10385714 | F20L2 | Almond -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Almond |
23 | 00630414973227 | 10385774 | F284L2 | Turkey Meat-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Turkey Meat |
24 | 00630414972947 | 10385998 | K84L2 | Sunflower-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Sunflower |
25 | 00630414972527 | 10385789 | F306L2 | Lime-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Lime |
26 | 00630414971377 | 10373705 | LTBCVM | TBG CVM - IMMULITE - CONS | JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 1 | IMMULITE® Systems TBG Calibration Verification Material TBG |
27 | 00630414971247 | 10373691 | LFT4CVM | Free T4 CVM - IMMULITE - | JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 1 | IMMULITE® Systems F4 Calibration Verification Material Free T4 |
28 | 00630414971155 | 10373682 | LBRCVM | BR-MA - IMMULITE - CONS | JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 1 | IMMULITE® Systems BR-MA Calibration Verification Material |
29 | 00630414970677 | 10360575 | A316L2 | Dermatophagoides pteronyssinus-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ nDer p 2 |
30 | 00630414970653 | 10360573 | A3050L2 | Aspergillus restrictus-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ nAsp r 1 |
31 | 00630414970103 | 10381630 | LKT31 | T3 Total - IMMULITE - RGT - 100 Tests | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | IMMULITE®/IMMULITE® 1000 Systems T3 Total T3 |
32 | 00630414969343 | 10385667 | E82L4 | Rabbit Epithelium-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Rabbit Epithelium |
33 | 00630414966298 | 10381425 | LKGB1 | IGF BP3 - IMMULITE - RGT - 100 Tests | CFL | RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE | 1 | IMMULITE®/IMMULITE® 1000 Systems BP3 IGFBP-3 |
34 | 00630414966137 | 10380867 | LKIE1 | IgE - IMMULITE - RGT - 100 Tests | JHR | RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) | 2 | IMMULITE®/IMMULITE® 1000 Systems TIE Total IgE |
35 | 00630414965925 | 10386023 | M207L2 | Aspergillus -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Aspergillus niger |
36 | 00630414965680 | 10385960 | I70L2 | Imported Fire Ant -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Imported Fire Ant |
37 | 00630414965598 | 10385718 | F214L2 | Spinach-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Spinach |
38 | 00630414965567 | 10385726 | F221L2 | Coffee-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Coffee |
39 | 00630414965437 | 10386151 | W2L2 | Western Ragweed -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Western Ragweed |
40 | 00630414965383 | 10386131 | W10L2 | Lamb#s Quarters -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Lambs Quarters |
41 | 00630414965376 | 10386130 | TP9L4 | Tree Panel 9 - IMMULITE - RGT - 40 test | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tree Panel 9 |
42 | 00630414965369 | 10386128 | TP7L4 | Tree Panel 7 - IMMULITE - RGT - 40 test | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tree Panel 7 |
43 | 00630414965352 | 10386126 | TP6L4 | Tree Panel 6 - IMMULITE - RGT - 40 test | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tree Panel 6 |
44 | 00630414965338 | 10386122 | TP4L4 | Tree Panel 4 - IMMULITE - RGT - 40 test | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tree Panel 4 |
45 | 00630414965154 | 10386057 | T11L2 | Sycamore -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Sycamore |
46 | 00630414965079 | 10386042 | M6L4 | Alternaria tenuis-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Alternaria tenuis |
47 | 00630414964874 | 10380900 | LKVB1 | Vitamin B12 - IMMULITE - RGT - 100 Tests | CDD | RADIOASSAY, VITAMIN B12 | 2 | IMMULITE®/IMMULITE® 1000 Systems VB Vitamin B12 |
48 | 00630414964607 | 10381628 | LKRT5 | TSH - IMMULITE - RGT - 500 Tests | JLW | RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE | 2 | IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH |
49 | 00630414964591 | 10381637 | LKRT1 | TSH - IMMULITE - RGT - 100 Tests | JLW | RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE | 2 | IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH |
50 | 00630414964331 | 10380969 | LKOP1 | CA 125 - IMMULITE - RGT - 100 Tests | LTK | TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125) | 2 | IMMULITE®/IMMULITE® 1000 Systems OV OM-MA (CA 125) |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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 |
2 | 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. |
3 | 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. |
4 | 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. |
5 | 10859035006245 | 84R2 | Alere Rubella-plus® | ALERE NORTH AMERICA, LLC | ||
6 | 10758750004997 | 8536195 | 8536195 | VITROS Immunodiagnostic Products Rubella IgG Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
7 | 10758750004546 | 8209074 | 8209074 | VITROS Immunodiagnostic Products Rubella IgG Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
8 | 10743816001034 | BSP-171-10-01 | BSP-171-10-01 | BioSign® Rubella card; 10 Test kit; CE | BioSign® Rubella card | PRINCETON BIOMEDITECH CORPORATION |
9 | 10743816001027 | BSP-171-35-01 | BSP-171-35-01 | BioSign® Rubella card; 35 Test kit; CE | BioSign® Rubella card | PRINCETON BIOMEDITECH CORPORATION |
10 | 05391516747011 | 2325361 | 2325361 | Captia™ Rubella IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
11 | 05391516747004 | 2325301 | 2325301 | Captia™ Rubella IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
12 | 05391516746878 | 828102 | Wash Buffer Concentrate Type I, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
13 | 05391516746786 | 617134 | Serum Diluent Type I | Trinity Biotech | CLARK LABORATORIES, INC. | |
14 | 05391516746748 | 616134 | Serum Diluent Type I | Trinity Biotech | CLARK LABORATORIES, INC. | |
15 | 05391516746533 | 525700 | Substrate Solution (TMB) | Trinity Biotech | CLARK LABORATORIES, INC. | |
16 | 05391516746526 | 915401 | Stop Solution | Trinity Biotech | CLARK LABORATORIES, INC. | |
17 | 05391516746519 | 827102 | Wash Buffer Concentrate Type I, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
18 | 05391516743457 | 2325360 | 2325360 | Captia™ Rubella IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
19 | 05391516743440 | 2325350 | 2325350 | Captia™ Rubella IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
20 | 05391516743433 | 2325300 | 2325300 | Captia™ Rubella IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
21 | 04015630940257 | 07027796190 | 07027796190 | Elecsys Rubella IgM | ROCHE DIAGNOSTICS GMBH | |
22 | 04015630940240 | 07027770190 | 07027770190 | Elecsys Rubella IgG | ROCHE DIAGNOSTICS GMBH | |
23 | 04015630939275 | 4618831160 | 4618831160 | Elecsys Rubella IgM Immunoassay | ROCHE DIAGNOSTICS GMBH | |
24 | 04015630939251 | 4618793160 | 4618793160 | Elecsys Rubella IgG Immunoassay | ROCHE DIAGNOSTICS GMBH | |
25 | 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 | |
26 | 00850487007395 | RUB M | Q01-110 | Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
27 | 00850487007388 | RUB G | Q01-100 | Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
28 | 00850487007074 | RUB G | Q01-100 | Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
29 | 00850487007067 | RUB M | Q01-110 | Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
30 | 00847865012577 | SW4.1_V1 | 6653860D | Manual & CDs, Rubella & CMV IgM IFU, SW4.1_v1, U.S Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
31 | 00847865011006 | SW4.1_V1 | 6653870D | Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
32 | 00847865010696 | 25174 | 25174 | Rubella IgM EIA | Bio-Rad Laboratories, Inc. | BIO-RAD LABORATORIES, INC. |
33 | 00847865010689 | 25173 | 25173 | Rubella IgG EIA | Bio-Rad Laboratories, Inc. | BIO-RAD LABORATORIES, INC. |
34 | 00847865003186 | SW4_ V3 | 6653870C | Rubella & CMV Assay Protocol File CD, SW4_v3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
35 | 00847865003179 | SW4_V3 | 6653860C | Manual & CDs, Rubella & CMV IgM IFU, SW4_v3, US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
36 | 00847865001175 | 6653850 | 6653850 | Rubella & CMV IgM Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
37 | 00817273020211 | 720-380 | "720-380 VZV IgG Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
38 | 00817273020204 | 720-370 | "720-370 Rubella IgM Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
39 | 00817273020198 | 720-360 | "720-360 Rubella IgG Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
40 | 00816057020522 | NC-800096-AM | NC-800096-AM | Detection of Rubella Virus Antibody | ASI Rubella IgM EIA Test | ARLINGTON SCIENTIFIC, INC. |
41 | 00816057020515 | NC-800096-AG | NC-800096-AG | Detection of Rubella Virus Antiboby | ASI Rubella IgG EIA Test | ARLINGTON SCIENTIFIC, INC. |
42 | 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. |
43 | 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. |
44 | 00630414976730 | 10469599 | LRUBCM | Rubella IGG - IMMULITE - CTL | IMMULITE® Systems RUB CONTROL Rubella IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
45 | 00630414976716 | 10469597 | LRMCM | Rubella IGM - IMMULITE - CTL | IMMULITE® Systems RUM CONTROL Rubella IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
46 | 00630414971582 | 10374044 | LKRM1(D) | IMMULITE®/IMMULITE® 1000 Systems Rubella IgM | IMMULITE®/IMMULITE® 1000 Systems Rubella IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
47 | 00630414971469 | 10374021 | L2KRM2(D) | Rubella IgM Ab - IMMULITE - RGT - 200 tests | IMMULITE® 2000 Systems RUM Rubella IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
48 | 00630414964614 | 10381292 | LKRUB1 | Rubella IgG Ab - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
49 | 00630414962061 | 10381305 | L2KRUB6 | Rubella IgG Ab - IMMULITE - RGT - 600 Tests | IMMULITE® 2000 Systems RUB Rubella Quantitative IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
50 | 00630414962054 | 10381338 | L2KRUB2 | Rubella IgG Ab - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems RUB Rubella Quantitative IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |