FDA.reportPublic FDA data

Test-mate ChE Cholinesterase Test System

Primary DI
00860010612200
Brand
Test-mate ChE Cholinesterase Test System
Company
Eqm Research, Inc.
Model
400
Catalog number
400
Device description
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).
Published
2023-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIHColorimetry, Cholinesterase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIHColorimetry, CholinesteraseClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961656000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961656000TEST-MATE CHE CHOLINESTERASE TEST SYSTEMEqm Research, Inc.1996-11-26DIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010612200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010612200008600106122008600106122000860010612200

GMDN Terms#

Term, Definition table
TermDefinition
Acetylcholinesterase IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the enzyme acetylcholinesterase in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
513-661-0560jpe@eqmresearch.com

Regulatory Flags#

DUNS number
803114859
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010612217AChE Assay Kit4604602023-07-31
00860010612224PChE Assay Kit4704702023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010612217AChE Assay KitEqm Research, Inc.DIH2023-07-31
00860010612224PChE Assay KitEqm Research, Inc.DIH2023-07-31
10673486001488Teco Diagnostics Cholinesterase Reagent SetTECO DIAGNOSTICSDIH2023-07-26
06971674862932BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862949BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862956BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862963BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862970BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862987BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862994BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863007BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863014BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863021BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863038BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863045BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863052BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
00630414611044Atellica CH Cholinesterase_2Siemens Healthcare Diagnostics Inc.DIH2023-06-29
00630414305042Atellica CH Cholinesterase_2Siemens Healthcare Diagnostics Inc.DIH2023-06-29
08800055732985ARENA StarARUM DENTISTRY Co., Ltd.DIH2023-03-31
04015630991549CholinesteraseRoche Diagnostics GmbHDIH2021-06-28
04015630920945Cholinesterase Gen.2Roche Diagnostics GmbHDIH2021-01-18
00630414465401ADVIA® Chemistry CHE Cholinesterase ReagentsSiemens Healthcare Diagnostics Inc.DIH2020-09-24
00630414510149ADVIA® Chemistry CHE Cholinesterase ReagentsSiemens Healthcare Diagnostics Inc.DIH2020-09-24
00630414596273Atellica CH CHESiemens Healthcare Diagnostics Inc.DIH2020-09-24
00842768014178Dimension® Flex® reagent cartridge PCHESiemens Healthcare Diagnostics Inc.DIH2020-09-24
00842768015373Dimension Vista® Flex® reagent cartridge PCHESiemens Healthcare Diagnostics Inc.DIH2020-09-24
10758750000241VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DIH2020-04-18
10758750004225VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DIH2020-04-18
07613336133620Cholinesterase Gen.2Roche Diagnostics GmbHDIH2020-03-05
05055273201093BUTYRYL CHOLINESTERASE (CHE)RANDOX LABORATORIES LIMITEDDIH2019-06-03