Who else makes this device?

Name: DRI T-Uptake Calibrator Kit
Brand: DRI T-Uptake Calibrator Kit

Clinical Chemistry › Test SystemsRadioassay, Triiodothyronine Uptake

DRI T-Uptake Calibrator Kit

Catalogue number 0738, listed by Microgenics Corporation, United States, under Radioassay, Triiodothyronine Uptake. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (1), Beijing (1).

Chinese manufacturers registered for FDA product code KHQ
Manufacturer	City	Province	Registered as	Device types
Shenzhen Yhlo Biotech Co., Ltd.	Shenzhen	Guangdong	Manufacturer	19
Beijing Hotgen Biotech Co., Ltd.	Beijing	Beijing	Manufacturer	13

Record

Regulatory record for DRI T-Uptake Calibrator Kit
Listed by	Microgenics Corporation, United States
FDA product code	KHQ
Device type	Radioassay, Triiodothyronine Uptake
Device class	Class 2
Regulation	21 CFR 862.1715
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2016-09-24
Record revised	2024-02-05 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for DRI T-Uptake Calibrator Kit
Catalogue number	Size	Status
0738		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Architect	Abbott Laboratories	2
Atellica IM Tup	Siemens Healthcare Diagnostics Inc	2
Advia Centaur® Tup	Siemens Healthcare Diagnostics Inc	2
Vitros	Ortho-Clinical Diagnostics, Inc.	2
T3-Uptake Elisa	DRG Instruments Gesellschaft mit beschränkter Haftung	1
Dimension® Flex® reagent cartridge TU	Siemens Healthcare Diagnostics Inc	1
Elecsys T-Uptake	Roche Diagnostics Gmbh	1
T3 Uptake 125I RIA 200 Tube Kit	Mp Biomedicals, LLC	1
Elecsys Tuptake Assay	Roche Diagnostics Gmbh	1
ST AIA-Pack T-U	Tosoh Corp.	1
T3 Uptake 125I RIA Kit	Mp Biomedicals, LLC	1
iFlash-FT3	Shenzhen Yhlo Biotech Co., Ltd.	1

Showing 12 of 23. All products under Radioassay, Triiodothyronine Uptake

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K872447	1987-08-21

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.