Product code KHQ
- Device name
- Radioassay, Triiodothyronine Uptake
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1715
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K981375 | ACE T UPTAKE REAGENT TU CALIBRATORS | Schiapparelli Biosystems, Inc. | 1998-06-10 |
| K980088 | T-UPTAKE MICROPLATE EIA | Monobind | 1998-02-04 |
| K970539 | CHIRON DIAGNOSTICS ACS:180TU P | Chiron Diagnostics Corp. | 1997-03-24 |
| K964308 | VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-11-27 |
| K961488 | ELECSYS T-UPTAKE ASSAY | Boehringer Mannheim Corp. | 1996-06-12 |
| K954807 | CEDIA T UPTAKE ASSAY | Boehringer Mannheim Corp. | 1995-12-21 |
| K951586 | T-UPTAKE EIA TEST | Diagnostic Reagents, Inc. | 1995-05-15 |
| K933414 | STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | 1994-11-22 |
| K934312 | AXSYM(TM) T-UPTAKE | Abbott Laboratories | 1994-06-21 |
| K935816 | VIDAS T UPTAKE | Biomerieux Vitek, Inc. | 1994-03-22 |
| K926220 | T3 UPTAKE CHEMILUMINESCENCE ASSAY | Nichols Institute Diagnostics | 1993-11-17 |
| K931294 | IQ TUPTAKE ASSAY | Becton Dickinson Advanced Diagnostics | 1993-07-22 |
| K926443 | COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS | Roche Diagnostic Systems, Inc. | 1993-05-20 |
| K925257 | CIBA CORNING ACS T UPTAKE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1992-12-28 |
| K923676 | VISTA THYROXINE UPTAKE ASSAY | Syva Co. | 1992-10-09 |
| K913663 | AIA-PACK T-U | Tosoh Corp. | 1991-09-30 |
| K911912 | SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) | Serono-Baker Diagnostics, Inc. | 1991-09-18 |
| K911093 | CIBA CORNING ACS T UPTAKE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-04-29 |
| K903396 | IL T UPTAKE ASSAY SYSTEM | Instrumentation Laboratory CO | 1990-10-12 |
| K902748 | SEROZYME FREE T3 IMMUNOASSAY | Advanced Magnetics, Inc. | 1990-08-09 |
| K902797 | OPUS TM T-UPTAKE TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-07-30 |
| K896925 | T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT | In Vitro Diagnostics, Inc. | 1990-01-18 |
| K895186 | FIAGEN T3 UPTAKE CATALOGUE #101-402 | Cyberfluor, Inc. | 1989-11-08 |
| K894145 | EMIT T-UPTAKE ASSAY | Syva Co. | 1989-09-05 |
| K892224 | D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN | Photec Diagnostics, Inc. | 1989-06-16 |
| K891068 | VENTREX COATED TUBE T3 UPTAKE | Ventrex Laboratories, Inc. | 1989-04-10 |
| K885259 | ACA THYRONINE UPTAKE (TU E) METHOD | The DU Pont Co. | 1989-02-17 |
| K883765 | TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE | Biotecx Laboratories, Inc. | 1988-10-31 |
| K883085 | T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS | Serono Diagnostics, Inc. | 1988-09-09 |
| K881855 | EMIT CONVENIENCE PACK: T-UPTAKE ASSAY | Syva Co. | 1988-06-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04048474032673 | T3-Uptake ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 10758750033843 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2023-03-28 |
| 06925912718482 | iFlash-FT3 | Shenzhen YHLO Biotech Co., Ltd. | 2022-10-26 |
| 04560189212121 | AIA-PACK T-U CALIBRATOR SET | TOSOH CORPORATION | 2019-07-25 |
| 14560189212135 | ST AIA-PACK T-U | TOSOH CORPORATION | 2019-07-25 |
| 14560189212128 | AIA-PACK T-U CALIBRATOR SET | TOSOH CORPORATION | 2019-07-25 |
| 24560189212132 | ST AIA-PACK T-U | TOSOH CORPORATION | 2019-07-25 |
| 00840239032676 | T3-Uptake ELISA | DRG International Inc | 2019-03-20 |
| 00816870021591 | T3 Uptake AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021607 | T3 Uptake AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870023038 | T3 Uptake AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870023045 | T3 Uptake AccuLite CLIA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00380740131548 | Alinity | Abbott Ireland Diagnostics | 2018-10-22 |
| 00630414600253 | Atellica IM Tup | Siemens Healthcare Diagnostics Inc. | 2018-02-06 |
| 00630414600246 | Atellica IM Tup | Siemens Healthcare Diagnostics Inc. | 2018-02-06 |
| 04015630940530 | Elecsys T-Uptake | Roche Diagnostics GmbH | 2017-04-14 |
| 00817830022566 | T3 Uptake 125I RIA 200 Tube Kit | MP BIOMEDICALS, LLC | 2017-01-09 |
| 00817830022429 | T3 Uptake 125I RIA Kit | MP BIOMEDICALS, LLC | 2016-10-20 |
| 00884883003453 | DRI T-Uptake | Microgenics Corporation | 2016-10-03 |
| 00842768005695 | Dimension® Flex® reagent cartridge TU | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768015496 | Dimension Vista® Flex® reagent cartridge TU | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00884883005556 | DRI T-Uptake Calibrator Kit | Microgenics Corporation | 2016-09-24 |
| 00630414177120 | ADVIA Centaur® Tup | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414177137 | ADVIA Centaur® Tup | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630899579 | Elecsys Tuptake Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630916030 | TUptake | Roche Diagnostics GmbH | 2016-09-20 |
| 00884883005662 | CEDIA T Uptake | Microgenics Corporation | 2016-09-12 |
| 10758750009145 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |
| 00380740003517 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740042523 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |