Radioassay, Triiodothyronine Uptake
Clinical Chemistry · 21 CFR 862.1715
Recent MDR events
4 adverse event reports on file
- ELECSYS T-UPTAKE ASSAYMay 28, 2021MalfunctionRoche Diagnostics1823260-2021-01600
- ELECSYS T-UPTAKE ASSAYFeb 15, 2018MalfunctionRoche Diagnostics1823260-2018-00457
- ELECSYS T-UPTAKE ASSAYOct 31, 2017InjuryRoche Diagnostics1823260-2017-02490
- T-UPTAKEMay 27, 2011MalfunctionRoche Diagnostics1823260-2011-02816
Event type breakdown
Most-reported manufacturers
Product problems
Reported product problem codes, most common first
Trend for “Low Test Results”
No history to chart.
Recalls
1 recall events for this product code
Registered firms
47 firms currently registered for this product code
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Abbott Gmbh
Wiesbaden Hesse, DE
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Diamond Diagnostics Inc.
Budapest, HU
Drg Instruments Gmbh
MARBURG Hesse, DE
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Beijing Hotgen Biotech Co., Ltd.
Beijing, CN
Alfa Wassermann
West Caldwell, NJ, US
Shenzhen Yhlo Biotech Co., Ltd.
Shenzhen Guangdong, CN
Monobind, Inc.
Lake Forest, CA, US
Siemens Healthcare Diagnostics Manufacturing Ltd.
SWORDS Dublin, IE
Tosoh Bioscience, Inc.
Grove City, OH, US
Tosoh Corp.
Chuo-ku Tokyo, JP
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Fisher Diagnostics
MIDDLETOWN, VA, US
Siemens Healthcare Diagnostics Inc.
E Walpole, MA, US
Drg International, Inc.
Springfield, NJ, US
510(k) clearances
93 clearances for this product code
- Schiapparelli Biosystems, Inc.Jun 10, 1998
K981375 · ACE T UPTAKE REAGENT TU CALIBRATORS
- MonobindFeb 4, 1998
K980088 · T-UPTAKE MICROPLATE EIA
- Chiron Diagnostics Corp.Mar 24, 1997
K970539 · CHIRON DIAGNOSTICS ACS:180TU P
- Johnson & Johnson Clinical Diagnostics, Inc.Nov 27, 1996
K964308 · VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)
- Boehringer Mannheim Corp.Jun 12, 1996
K961488 · ELECSYS T-UPTAKE ASSAY
- Boehringer Mannheim Corp.Dec 21, 1995
K954807 · CEDIA T UPTAKE ASSAY
- Diagnostic Reagents, Inc.May 15, 1995
K951586 · T-UPTAKE EIA TEST
- Baxter Diagnostics, Inc.Nov 22, 1994
K933414 · STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY