| 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 | 20816467020031 | Testo Immunoassay | 25000041 | 30 Test Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP Testo Kit (30) | |
| 22 | 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 |
| 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 | B24225HCGHUE010 | 25-HCGHU-E01 | 25-HCGHU-E01 | The Human Chorionic Gonadotropin ELISA is intended for use in the quantitative d The Human Chorionic Gonadotropin ELISA is intended for use in the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting. | Human Chorionic Gonadotropin ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
| 2 | 30014613202660 | hCG FIA | 20266 | Sofia hCG 50T | Sofia | QUIDEL CORPORATION |
| 3 | 30014613202295 | hCG FIA | 20229 | Sofia hCG 50T, US | Sofia | QUIDEL CORPORATION |
| 4 | 30014613201120 | 20112 | 20112 | RpdVue hCG 25T | QuickVue | QUIDEL CORPORATION |
| 5 | 30014613201106 | One-Step hCG Combo Test | 20110 | QkVue HCG Combo, 50T | QuickVue | QUIDEL CORPORATION |
| 6 | 30014613201090 | One-Step hCG Urine Test | 20109 | QkVue hCG Urine 25T | QuickVue | QUIDEL CORPORATION |
| 7 | 30014613001799 | hCG S/U Test | 00179 | QkVue+ hCG S/U, 90T | QuickVue+ | QUIDEL CORPORATION |
| 8 | 30014613001782 | hCG S/U Test | 00178 | QkVue+ hCG S/U, 30T | QuickVue+ | QUIDEL CORPORATION |
| 9 | M90107RD70010 | 07RD7001 | 07RD7001 | immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG) | QuickProfile™ HCG Test Strip | LUMIQUICK DIAGNOSTICS, INC. |
| 10 | 20888277703572 | MPH12325HCG | MPH12325HCG | TEST,HCG,PREGNANCY,URINE,CASS,25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
| 11 | 20888277703565 | MPH11325HCG | MPH11325HCG | TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
| 12 | 20885380181198 | CH24 | CH24 | Cardinal Health hCG Combo Cassette | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 13 | 20885380181181 | CH23 | CH23 | Cardinal Health Premium hCG Combo Cassette | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 14 | 20885380181174 | CH22 | CH22 | Cardinal Health Premium hCG Urine Cassette | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 15 | 20885380181150 | CH21 | CH21 | Cardinal Health hCG Urine Dipstick | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 16 | 20885380020268 | B1077-23 | B1077-23 | hCG Combo Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 17 | 20885380020251 | B1077-22 | B1077-22 | hCG Cassette Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 18 | 20885380020244 | B1077-21 | B1077-21 | hCG Dipstick Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 19 | 20612479202768 | 5002 | TEST KIT, PREG HCG URINE/SERUM | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 20 | 20612479202751 | 5000 | TEST KIT, PREGNANCY HCG DIPSTI | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 21 | 20612479202744 | 5001 | TEST KIT, PREG HCG CASSETTE WA | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 22 | 20607415000119 | 82789 | hCG Dipstick MMC | Moore Medical | MOORE MEDICAL LLC | |
| 23 | 20607415000096 | 82791 | HCG Serum/Urine MMC | Moore Medical | MOORE MEDICAL LLC | |
| 24 | 20607415000072 | 82790 | hCG Cassette MMC | Moore Medical | MOORE MEDICAL LLC | |
| 25 | 15099590776886 | 43025 | 43025 | Icon 25 HCG, Box of 25 Tests | ICON 25 hCG | BECKMAN COULTER, INC. |
| 26 | 15099590625948 | 395097 | 395097 | Icon 20 HCG, Box of 25 Tests | Icon | BECKMAN COULTER, INC. |
| 27 | 14560189210841 | N/A | ST AIA-PACK HCG | TOSOH CORPORATION | ||
| 28 | 14560189210063 | N/A | ST AIA-PACK βHCG | TOSOH CORPORATION | ||
| 29 | 10894175000081 | DACD 113029-1-19 | 113029-1-19 | OneStep hCG Combo Urine/Serum RapiCard™ InstaTestA collection of reagents and ot OneStep hCG Combo Urine/Serum RapiCard™ InstaTestA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. | OneStep | DIAGNOSTIC AUTOMATION, INC. |
| 30 | 10888277191877 | MPH12025HCG | MPH12025HCG | TEST,HCG,PREGNANCY,URINE,CASS, 25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
| 31 | 10885632116308 | MC02SU | Kit Human Chorionic Gonadotropin Pregnancy Test Urine/Serum 25-Test Not Made Wit Kit Human Chorionic Gonadotropin Pregnancy Test Urine/Serum 25-Test Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
| 32 | 10885632116285 | MC001U | Kit Human Chorionic Gonadotropin Pregnancy Test Urine 25-Test Not Made With Natu Kit Human Chorionic Gonadotropin Pregnancy Test Urine 25-Test Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
| 33 | 10884389191880 | MPH22025HCG | MPH22025HCG | TEST,HCG,PREGNANCY,COMBO,CASS,20/10 MIU | Medline | MEDLINE INDUSTRIES, INC. |
| 34 | 10884389191873 | MPH11025HCG | MPH11025HCG | TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
| 35 | 10816467020126 | hCG Immunoassay | 25000044 | 30 Test Ported hCG Immunoassay Kit | FastPack® IP hCG Kit (30) | QUALIGEN INC. |
| 36 | 10815845020130 | 92210 | AlereTM | ALERE SAN DIEGO, INC. | ||
| 37 | 10815845020123 | 92215 | AlereTM | ALERE SAN DIEGO, INC. | ||
| 38 | 10815845020116 | 92225 | AlereTM | ALERE SAN DIEGO, INC. | ||
| 39 | 10815845020109 | 92217 | AlereTM | ALERE SAN DIEGO, INC. | ||
| 40 | 10815845020093 | 92211 | AlereTM | ALERE SAN DIEGO, INC. | ||
| 41 | 10796918000108 | 02-2493 | HCG Combo Cassette Test | Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 42 | 10796918000092 | 02-2489 | INSTANT-VIEW HCG Combo Cassette Test | INSTANT-VIEW Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 43 | 10796918000085 | 02-2488 | INSTANT-VIEW HCG Combo Dip-Strip Test | INSTANT-VIEW Pregnancy Combo Dip-Strip Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 44 | 10796918000078 | 02-2487-25 | INSTANT-VIEW HCG Urine Dip-Strip Test | INSTANT-VIEW Pregnancy Urine Dip-Strip Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 45 | 10796918000061 | 02-2487 | INSTANT-VIEW HCG Urine Dip-Strip Test | INSTANT-VIEW Pregnancy Urine Dip-Strip Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 46 | 10796918000054 | 02-2486 | Instant-View HCG Urine Cassette,4mm | INSTANT-VIEW Pregnancy Urine Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 47 | 10796918000047 | 02-2484 | Instant-View HCG Combo Cassette, 4mm | INSTANT-VIEW Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 48 | 10796918000030 | 02-2483 | INSTANT-VIEW HCG Combo Cassette Test | INSTANT-VIEW Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 49 | 10796918000023 | 02-2482 | INSTANT-VIEW HCG Urine Cassette Test | Insant-View Pregnancy Urine Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 50 | 10763924864208 | PF864 | Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine) | Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine) | JANT PHARMACAL CORPORATION |