Who else makes this device?

Name: Test-mate ChE Cholinesterase Test System
Brand: Test-mate ChE Cholinesterase Test System

Clinical Chemistry › Toxicology Test SystemsColorimetry, Cholinesterase

Test-Mate ChE Cholinesterase Test System

For the quantitative determination of Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnostic use. For laboratory use by trained laboratory technicians only.…

Registry build 21.09.26

For the quantitative determination of Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnostic use. For laboratory use by trained laboratory technicians only. For use only with the AChE Assay Kit (Model 460) and the PChE Assay Kit (Model 470).

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code DIH
Manufacturer	City	Province	Registered as	Device types
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70

Record

Regulatory record for Test-mate ChE Cholinesterase Test System
Listed by	EQM Research, Inc., United States
FDA product code	DIH
Device type	Colorimetry, Cholinesterase
Device class	Class 1
Regulation	21 CFR 862.3240
Establishment	Manufacturer
510(k)	K961656
Record published	2023-07-31

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	expiry date, manufacturing date, serial number
Storage	Storage environment temperature 15 to 30 °C

Catalogue Numbers

Catalogue numbers for Test-mate ChE Cholinesterase Test System
Catalogue number	Size	Status
400		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Biobase	Biobase Biodustry(Shandong)Co., Ltd.	13
Vitros	Ortho-Clinical Diagnostics, Inc.	2
Advia® Chemistry CHE Cholinesterase Reagents	Siemens Healthcare Diagnostics Inc	2
Cholinesterase Gen.2	Roche Diagnostics Gmbh	2
Butyryl Cholinesterase (CHE)	Randox Laboratories Limited	2
Dimension Vista® Flex® reagent cartridge Pche	Siemens Healthcare Diagnostics Inc	1
AChE Assay Kit	EQM Research, Inc.	1
Arena Star	Arum Dentistry Co., Ltd.	1
PChE Assay Kit	EQM Research, Inc.	1
Atellica CH CHE	Siemens Healthcare Diagnostics Inc	1
Cholinesterase	Roche Diagnostics Gmbh	1
Atellica CH Cholinesterase_2	Siemens Healthcare Diagnostics Inc	1

Showing 12 of 14. All products under Colorimetry, Cholinesterase

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K961656	1996-11-26

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.