Who else makes this device?

Clinical Chemistry › Test SystemsRadioimmunoassay, Total Thyroxine

T4 SBS AccuLite Clia Test System – 192 Wells

Catalogue number 8275-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Total Thyroxine. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jilin (1), Hebei (1), Guangdong (1).

Chinese manufacturers registered for FDA product code CDX
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Shijiazhuang Hipro Biotechnology Co., Ltd.	Shijiazhuang	Hebei	Manufacturer	22
Shenzhen Yhlo Biotech Co., Ltd.	Shenzhen	Guangdong	Manufacturer	19
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19
Beijing Hotgen Biotech Co., Ltd.	Beijing	Beijing	Manufacturer	13

Record

Regulatory record for T4 SBS AccuLite Clia Test System – 192 Wells
Listed by	Monobind, Inc., United States
FDA product code	CDX
Device type	Radioimmunoassay, Total Thyroxine
Device class	Class 2
Regulation	21 CFR 862.1700
Establishment	Specification developer, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2019-02-11
Record revised	2024-09-16 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 2 to 8 °C
Sizes	Width 7.75 in

Catalogue Numbers

Catalogue numbers for T4 SBS AccuLite Clia Test System – 192 Wells
Catalogue number	Size	Status
8275-300	Width 7.75 in	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Elecsys T4	Roche Diagnostics Gmbh	3
Total T4 MAb 125I RIA Kit	Mp Biomedicals, LLC	3
Advia Centaur® T4	Siemens Healthcare Diagnostics Inc	2
AutoDELFIA Neonatal Thyroxine (T4) kit	Wallac OY	2
Elecsys CalSet T4	Roche Diagnostics Gmbh	1
T4 AccuBind Elisa Test System – 96 Wells	Monobind, Inc.	1
Mycoplasma hominis IgG Elisa	DRG International, Inc.	1
Atellica IM T4 DIL	Siemens Healthcare Diagnostics Inc	1
N-T4 AccuBind Elisa Test System – 960 Wells	Monobind, Inc.	1
N-T4 AccuBind Elisa Test System – 480 Wells	Monobind, Inc.	1
N-T4 AccuBind Elisa Test System – 96 Wells	Monobind, Inc.	1
iFlash-T4	Shenzhen Yhlo Biotech Co., Ltd.	1

Showing 12 of 31. All products under Radioimmunoassay, Total Thyroxine

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K921935	1992-07-07
K771221	1977-08-04

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.