Who else makes this device?

Clinical Chemistry › Test SystemsEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

T4 High Sensitivity AccuBind Elisa Test System – 96 Wells

Catalogue number 12825-300, listed by Monobind, Inc., United States, under Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine. 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

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shandong (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code KLI
Manufacturer	City	Province	Registered as	Device types
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19

Record

Regulatory record for T4 High Sensitivity AccuBind Elisa Test System – 96 wells
Listed by	Monobind, Inc., United States
FDA product code	KLI
Device type	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device class	Class 2
Regulation	21 CFR 862.1700
Establishment	Specification developer, Manufacturer, Exporter
Record published	2024-09-13

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 High Sensitivity AccuBind Elisa Test System – 96 wells
Catalogue number	Size	Status
12825-300	Width 7.75 in	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Architect	Abbott Ireland	4
DRI Thyroxine (T4)	Microgenics Corporation	2
Immulite® 2000 Systems TT4 Total T4	Siemens Healthcare Diagnostics Products GmbH	2
Alinity	Abbott Ireland	2
Immulite®/Immulite® 1000 Systems T4 Total T4	Siemens Healthcare Diagnostics Products GmbH	2
Total Thyroxine (T4) Elisa	DRG Instruments Gesellschaft mit beschränkter Haftung	1
Access Total T4	Beckman Coulter, Inc.	1
Total Thyroxine (tT4) Elisa	DRG Instruments Gesellschaft mit beschränkter Haftung	1
ACE	Alfa Wassermann	1
Cedia T4 Assay	Microgenics Corporation	1
AIA-Pack T4 Calibrator SET	Tosoh Corp.	1
ST AIA-Pack T4	Tosoh Corp.	1

Showing 12 of 30. All products under Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K030860	2003-08-22
K971709	1997-06-16

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.