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 | 00816467020136 | Multi-Analyte Controls | 25000056 | Two control levels for the following assays: TPSA, Testo, FT4, TSH, hCG | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | FastPack® Control Kit |
24 | 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) | |
25 | 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 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B24211TESHUE010 | 11-TESHU-E01 | 11-TESHU-E01 | Intended for the direct quantitative determination of Testosterone by an enzyme Intended for the direct quantitative determination of Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use. | Serum Testosterone ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
2 | B24211FTEHUE010 | 11-FTEHU-E01 | 11-FTEHU-E01 | For the direct quantitative determination of Free Testosterone by an enzyme immu For the direct quantitative determination of Free Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use. | Free Testosterone ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
3 | B085K021M60 | K021M-6 | Audit MicroControls Control LQ hs-CRP | AALTO SCIENTIFIC | ||
4 | B085K020M60 | K020M-6 | Audit MicroControls Control LQ Homocysteine | AALTO SCIENTIFIC | ||
5 | 50021292008609 | TRUEtrack PRE-PACK | A4002-75 | LEADER TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
6 | 30884389831216 | MPH3560 | MPH3560 | CONTROL,EVENCARE,G3 HI LO,PROF.USE ONLY | Medline | MEDLINE INDUSTRIES, INC. |
7 | 30816467020038 | Testo Immunoassay | 25000058 | 90 Test Ported Testo Immunoassay Kit | FastPack® IP Testo Kit (90) | QUALIGEN INC. |
8 | 30804084000144 | AGS-1112 | Test Strips a vial of 25 Test Strips | IDEAL LIFE Blood Glucose Test Strips 1 vial of 25 Test Strips | IDEAL LIFE INC | |
9 | 30014613337720 | 98202 | 98202 | Triage BNP Calibrators | Triage | QUIDEL CARDIOVASCULAR INC. |
10 | 30014613337713 | 98201 | 98201 | Triage BNP QC Controls | Triage | QUIDEL CARDIOVASCULAR INC. |
11 | 30014613337072 | 98814EU | 98814EU | Triage PLGF Control 2 | Triage | QUIDEL CARDIOVASCULAR INC. |
12 | 30014613337065 | 98813EU | 98813EU | Triage PLGF Control 1 | Triage | QUIDEL CARDIOVASCULAR INC. |
13 | 30014613337058 | 98714EU | 98714EU | Triage NT-proBNP Control 2 | Triage | QUIDEL CARDIOVASCULAR INC. |
14 | 30014613337041 | 98713EU | 98713EU | Triage NT-proBNP Control 1 | Triage | QUIDEL CARDIOVASCULAR INC. |
15 | 30014613337034 | 98015XR | 98015XR | Quidel Triage® BNP Calibration Verification | Triage | QUIDEL CARDIOVASCULAR INC. |
16 | 30014613337027 | 98014XR | 98014XR | Quidel Triage® BNP Control 2 | Triage | QUIDEL CARDIOVASCULAR INC. |
17 | 30014613337010 | 98013XR | 98013XR | Triage BNP Control 1 | Triage | QUIDEL CARDIOVASCULAR INC. |
18 | 30014613336747 | RPS-ID-20 | RPS-ID-20 | InflammaDry | InflammaDry | QUIDEL CORPORATION |
19 | 30014613311195 | M119 | M119 | QMol Trichomonas Control Set | Quidel Molecular | DIAGNOSTIC HYBRIDS, INC. |
20 | 30014613311171 | M117 | M117 | QMol Bordetella Control Set | Quidel Molecular | DIAGNOSTIC HYBRIDS, INC. |
21 | 30014613311164 | M116 | M116 | QMol GBS Control Set | Quidel Molecular | DIAGNOSTIC HYBRIDS, INC. |
22 | 30014613311157 | M115 | M115 | QMol Parainflu Control Set | Quidel Molecular | DIAGNOSTIC HYBRIDS, INC. |
23 | 30014613311102 | M110 | M110 | QMol Adeno Control Set | Quidel Molecular | DIAGNOSTIC HYBRIDS, INC. |
24 | 30014613311089 | M108 | M108 | QMol CDIFF Control Set | Quidel Molecular | DIAGNOSTIC HYBRIDS, INC. |
25 | 30014613002819 | 00281 | 00281 | hCG Ctrl Set - Serum | QuickVue | QUIDEL CORPORATION |
26 | 30014613002727 | 00272 | 00272 | hCG Ctrl Set - Urine | QuickVue | QUIDEL CORPORATION |
27 | MHC18490112 | 849011 | BluLink Test Strips 50ct | BluLink | MHC MEDICAL PRODUCTS, LLC | |
28 | MHC18100012 | 810001 | EasyTouch | MHC MEDICAL PRODUCTS, LLC | ||
29 | MHC18090112 | 809011 | HealthPro | MHC MEDICAL PRODUCTS, LLC | ||
30 | 20885380020275 | B1077-24 | B1077-24 | hCG Controls; 1 Set; IVD | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
31 | 20816467020345 | FastPack® IP SHBG 30 Immunoassay | 25000081 | 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls | FastPack® IP SHBG | QUALIGEN INC. |
32 | 20816467020345 | FastPack® IP SHBG 30 Immunoassay | 25000081 | 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls | FastPack® IP SHBG | QUALIGEN INC. |
33 | 20816467020345 | FastPack® IP SHBG 30 Immunoassay | 25000081 | 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls | FastPack® IP SHBG | QUALIGEN INC. |
34 | 20816467020031 | Testo Immunoassay | 25000041 | 30 Test Ported Testo Immunoassay Kit | FastPack® IP Testo Kit (30) | QUALIGEN INC. |
35 | 15430001412137 | 1 | In vitro transcript of Mycoplasma genitalium 23S RNA | Mycoplama genitalium IVT Wild type control | DIAGENODE | |
36 | 15430001412120 | 1 | PRD-06113 | In vitro transcript of mycoplasma genitalium 23S RNA including A2059G mutation | Mycoplasma genitamium macrolide resistance IVT A 2059G control | DIAGENODE |
37 | 15430001412113 | 1 | In vitro transcript of Mycoplama genitalium 23S RNA including A 2059C mutation | Mycoplasma genitalium macrolide resistance IVT A2059C Control | DIAGENODE | |
38 | 15430001412106 | 1 | PRD-06111 | In vitro transcript of Mycoplasma genitalium 23S RNA including A2058T mutation | Mycoplasma genitalium macrolide resistance IVT A2058T Controls | DIAGENODE |
39 | 15430001412090 | 1 | PRD-06110 | In vitro transcript of Mycoplasma genitalium 23S RNA including A2058G mutation | Mycoplasma genitalium macrolide resistance IVT A2058G Control | DIAGENODE |
40 | 15430001412083 | 1 | PRD-06109 | In vitro transcript of Mycoplasma genitalium 23S RNA including A2058C mutation | Mycoplasma genitalium Macrolide Resistance IVT A2058C Control | DIAGENODE |
41 | 15420045509382 | CLASS I CONTROL - C. GLABRATA | PRD-04522 | Aptima | HOLOGIC, INC. | |
42 | 15420045509375 | CLASS I CONTROL - C. ALBICANS | PRD-04521 | aptima | HOLOGIC, INC. | |
43 | 15420045509368 | CLASS I CONTROL - G. VAGINALIS | PRD-04520 | Aptima | HOLOGIC, INC. | |
44 | 15420045509351 | CLASS I CONTROL - L. CRISPATUS | PRD-04519 | Aptima | HOLOGIC, INC. | |
45 | 15099590750961 | 98202 | 98202 | The Access BNP Calibrators are intended to calibrate the Access BNP test for the The Access BNP Calibrators are intended to calibrate the Access BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems. | Access BNP Calibrators | BECKMAN COULTER, INC. |
46 | 15099590750954 | 98201 | 98201 | The Access BNP QC Controls are intended for monitoring the performance of the Ac The Access BNP QC Controls are intended for monitoring the performance of the Access BNP test using the Beckman Coulter Access Family of Immunoassay Systems. | Access BNP QC | BECKMAN COULTER, INC. |
47 | 15099590707194 | C26909 | C26909 | The Access hsTnI Calibrators are intended to calibrate the Access hsTnI assay fo The Access hsTnI Calibrators are intended to calibrate the Access hsTnI assay for quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems. | Access hsTnI Calibrators | BECKMAN COULTER, INC. |
48 | 15099590677398 | B83877 | B83877 | The Access Ostase QC is intended for monitoring system performance of the Access The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. | Access Ostase QC | BECKMAN COULTER, INC. |
49 | 15099590669706 | B23634 | B23634 | Unicel DxC SYNCHRON Systems HDL Calibrator | Synchron | BECKMAN COULTER, INC. |
50 | 15099590666361 | B38859 | Urine CSF Albumin Calibrator | AU | BECKMAN COULTER IRELAND INC. |