FDA.reportPublic FDA data

PChE Assay Kit

Primary DI
00860010612224
Brand
PChE Assay Kit
Company
Eqm Research, Inc.
Model
470
Catalog number
470
Device description
For the quantitative determination of Plasma 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 Test-mate ChE Cholinesterase Test System (Model 400). Contains materials for 96 tests.
Published
2023-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00860010612224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010612224008600106122248600106122240860010612224

GMDN Terms#

Term, Definition table
TermDefinition
Pseudocholinesterase IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the enzyme pseudocholinesterase 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
Lot or batch
true
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
00860010612200Test-mate ChE Cholinesterase Test System4004002023-07-31
00860010612217AChE Assay Kit4604602023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010612200Test-mate ChE Cholinesterase Test SystemEqm Research, Inc.DIH2023-07-31
00860010612217AChE 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