No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10816467020157 | Vit. D Immunoassay | 25000068, 25000073 | 30 Test Vit. D Immunoassay Complete Kit w/Cal and Control | MRG | System, Test, Vitamin D | FastPack® IP Vitamin D Kit Complete | |
2 | 10816467020126 | hCG Immunoassay | 25000044 | 30 Test Ported hCG Immunoassay Kit | JHI | Visual, Pregnancy Hcg, Prescription Use | FastPack® IP hCG Kit (30) | |
3 | 10816467020010 | TPSA Immunoassay | 25000001 | 50 Test Non-Ported TPSA Immunoassay Kit | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FastPack® Total PSA Kit (50) | |
4 | 00816467020372 | Pro System | 08000067, 08000067-R, 08000067-X | RoHS Compliant 7-chamber FastPack System | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | FastPack® Pro System |
5 | 00816467020075 | TPSA Verifier | 25000017 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Method Verification Kit - PSA | |
6 | 20816467020086 | TSH Immunoassay | 25000042 | 30 Test Ported TSH Immunoassay Kit | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FastPack® IP TSH Kit (30) | |
7 | 00816467020167 | PSA Controls | 25000003 | Two levels of controls for the following assays: TPSA, FPSAFPSA is not available Two levels of controls for the following assays: TPSA, FPSAFPSA is not available in the US. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Control Kit - PSA |
8 | 20816467020055 | FT4 Immunoassay | 25000043 | 30 Test Ported FT4 Immunoassay Kit | CEC | Radioimmunoassay, Free Thyroxine | FastPack® IP Free T4 Kit (30) | |
9 | 00816467020044 | Testo Cal | 25000014 | JIT | Calibrator, Secondary | 2 | Calibrator Kit - Testosterone | |
10 | 30816467020038 | Testo Immunoassay | 25000058 | 90 Test Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP Testo Kit (90) | |
11 | 20816467020017 | TPSA Immunoassay | 25000040 | 30 Test Ported TPSA Immunoassay Kit | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FastPack® IP Total PSA Kit (30) | |
12 | 10816467020034 | Testo Immunoassay | 25000009 | 50 Test Non-Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® Testo Kit (50) | |
13 | 00816467020105 | hCG Cal | 25000035 | JIT | Calibrator, Secondary | 2 | Calibrator Kit – hCG | |
14 | 00816467020143 | Vit. D Verifier | 25000064, 25000074 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Method Verification Kit - Vitamin D | |
15 | 10816467020386 | SARS-CoV-2 IgG Immunoassay | 25000085 | 90 Test Kit SARS-CoV-2 IgG Immunoassay | QKO | Reagent, Coronavirus Serological | FastPack SARS-CoV-2 IgG | |
16 | 00816467020020 | TPSA Cal | 25000002 | JIT | Calibrator, Secondary | 2 | Calibrator Kit - PSA | |
17 | 00816467020006 | IP System | 08000043, 08000043-R, 08000043-X | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | FastPack® IP System | |
18 | 00816467020099 | TSH Cal | 25000024 | JIT | Calibrator, Secondary | 2 | Calibrator Kit – TSH | |
19 | 00816467020068 | FT4 Cal | 25000016 | JIX | Calibrator, Multi-Analyte Mixture | 2 | Calibrator Kit – Free T4 | |
20 | 00816467020334 | IP System | 08000043-C, 08000043-CR | RoHS Compliant FastPack System | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | FastPack® IP System |
21 | 00816467020112 | hCG Diluent | 25000036 | Used to dilute the sample if the test result reads outside the assay range. Max Used to dilute the sample if the test result reads outside the assay range. Maximum two serial dilutions per sample. | JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | FastPack® IP hCG Diluent Kit (25) |
22 | 20816467020031 | Testo Immunoassay | 25000041 | 30 Test Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP Testo Kit (30) | |
23 | 30816467020014 | TPSA Immunoassay | 25000057 | 90 Test Ported TPSA Immunoassay Kit | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FastPack® IP Total PSA Kit (90) | |
24 | 20816467020345 | FastPack® IP SHBG 30 Immunoassay | 25000081 | 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls | JJX,JIT,CDZ | Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondar Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondary,Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP SHBG | |
25 | 10816467020348 | FastPack® IP SHBG 60 Immunoassay | 25000080 | 60 Test SHBG Immunoassay Complete Kit w/Calibrator and Control | JJX,JIT,CDZ | Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondar Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondary,Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP SHBG |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | EABA10090201 | 100-9020 | 100-9020 | BRT Chemistry Control is a human liquid assayed or control serum to monitor the BRT Chemistry Control is a human liquid assayed or control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert for the Abaxis Piccolo Express®. | BRT Liquid Assayed Chemistry Control with CRP | BIORESOURCE TECHNOLOGY |
2 | EABA10090101 | 100-9010 | 100-9010 | BRT Chemistry Control is a human liquid assayed or control serum to monitor the BRT Chemistry Control is a human liquid assayed or control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert for the Abaxis Piccolo Express®. | BRT Liquid Assayed Chemistry Control | BIORESOURCE TECHNOLOGY |
3 | 00884883012004 | OCRD-MP | MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control | MICROGENICS CORPORATION | ||
4 | 00884883011991 | OCRD-SP | MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control | MICROGENICS CORPORATION | ||
5 | 00884883011984 | OCRD-303 | MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control | MICROGENICS CORPORATION | ||
6 | 00884883011977 | OCRD-202 | MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control | MICROGENICS CORPORATION | ||
7 | 00884883011960 | OCRD-101 | MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control | MICROGENICS CORPORATION | ||
8 | 00884883011953 | OCRD-L | MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control | MICROGENICS CORPORATION | ||
9 | 00884883011946 | OCRD-UL | MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control | MICROGENICS CORPORATION | ||
10 | 00884883011601 | IC-V3 | MAS Immunology Liquid Assayed Immunology Control | MICROGENICS CORPORATION | ||
11 | 00884883011595 | IC-V2 | MAS Immunology Liquid Assayed Immunology Control | MICROGENICS CORPORATION | ||
12 | 00884883011588 | IC-V1 | MAS Immunology Liquid Assayed Immunology Control | MICROGENICS CORPORATION | ||
13 | 00884883006362 | URN5005 | SENTRY Urine Dipstick Control | MICROGENICS CORPORATION | ||
14 | 00884883005433 | OCR-SP | MAS Omni-CORE Liquid Assayed Integrated Chemistry Control | MICROGENICS CORPORATION | ||
15 | 00884883005426 | OCR-303 | MAS Omni-CORE Liquid Assayed Integrated Chemistry Control | MICROGENICS CORPORATION | ||
16 | 00884883005419 | OCR-202 | MAS Omni-CORE Liquid Assayed Integrated Chemistry Control | MICROGENICS CORPORATION | ||
17 | 00884883005402 | OCR-101 | MAS Omni-CORE Liquid Assayed Integrated Chemistry Control | MICROGENICS CORPORATION | ||
18 | 00884883005396 | OIM-SP | MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
19 | 00884883005389 | OIM-303 | MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
20 | 00884883005372 | OIM-202 | MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
21 | 00884883005365 | OIM-101 | MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
22 | 00884883005358 | OPRO-SP | MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
23 | 00884883005341 | OPRO-303 | MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
24 | 00884883005334 | OPRO-202 | MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
25 | 00884883005327 | OPRO-101 | MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
26 | 00884883004467 | 10014443 | MAS Alcohol/Ammonia | MICROGENICS CORPORATION | ||
27 | 00884883004412 | 10014444 | MAS CSF Liquid Assayed Cerebral Spinal Fluid | MICROGENICS CORPORATION | ||
28 | 00884883004399 | 10014182 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | MICROGENICS CORPORATION | ||
29 | 00884883004382 | 10014181 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | MICROGENICS CORPORATION | ||
30 | 00884883004375 | 10014180 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | MICROGENICS CORPORATION | ||
31 | 00884883004368 | 10014179 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | MICROGENICS CORPORATION | ||
32 | 00884883004207 | 10014152 | MAS ChemTrak H Liquid Assayed Chemistry Control | MICROGENICS CORPORATION | ||
33 | 00884883004191 | 10014151 | MAS ChemTrak H Liquid Assayed Chemistry Control | MICROGENICS CORPORATION | ||
34 | 00884883004184 | 10014150 | MAS ChemTrak H Liquid Assayed Chemistry Control | MICROGENICS CORPORATION | ||
35 | 00884883003972 | CSF-MP | MAS CSF Liquid Assayed Cerebrospinal Fluid Control | MICROGENICS CORPORATION | ||
36 | 00884883003811 | AAC-MP | MAS Alcohol/Ammonia | MICROGENICS CORPORATION | ||
37 | 00884883003804 | TUM-S1 | MAS T-Marker Liquid Assayed Tumor Marker Control | MICROGENICS CORPORATION | ||
38 | 00884883003798 | CHU-SP | MAS® ChemTRAK H Unassayed Control Sample Pack | MICROGENICS CORPORATION | ||
39 | 00884883003781 | CHU-3 | MAS ChemTRAK H Unassayed Liquid Unassayed Chemistry Control | MICROGENICS CORPORATION | ||
40 | 00884883003774 | CHU-2 | MAS ChemTRAK H Unassayed Liquid Unassayed Chemistry Control | MICROGENICS CORPORATION | ||
41 | 00884883003767 | CHU-1 | MAS ChemTRAK H Unassayed Liquid Unassayed Chemistry Control | MICROGENICS CORPORATION | ||
42 | 00884883003750 | CHA-SP | MAS® ChemTRAK H Liquid Assayed Chemistry Control | MICROGENICS CORPORATION | ||
43 | 00884883003743 | CHA-3 | MAS® ChemTRAK H Liquid Assayed Chemistry Control | MICROGENICS CORPORATION | ||
44 | 00884883003736 | CHA-2 | MAS® ChemTRAK H Liquid Assayed Chemistry Control | MICROGENICS CORPORATION | ||
45 | 00884883003729 | CHA-1 | MAS® ChemTRAK H Liquid Assayed Chemistry Control | MICROGENICS CORPORATION | ||
46 | 00884883003637 | LG-S1 | MAS Liquimmune Liquid Assayed Immunoassay Control | MICROGENICS CORPORATION | ||
47 | 00884883003613 | CAI-XLS | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | MICROGENICS CORPORATION | ||
48 | 00884883003606 | CAI-XL4 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | MICROGENICS CORPORATION | ||
49 | 00884883003569 | IC-S1 | MAS Immunology Liquid Assayed Immunology Control | MICROGENICS CORPORATION | ||
50 | 00884883003552 | IC-303 | MAS Immunology Liquid Assayed Immunology Control | MICROGENICS CORPORATION |