PChE Assay Kit 470

GUDID 00860010612224

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.

Eqm Research, Inc.

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Primary Device ID00860010612224
NIH Device Record Key56f7900b-9c24-4593-bfb3-53e3c64e31cd
Commercial Distribution StatusIn Commercial Distribution
Brand NamePChE Assay Kit
Version Model Number470
Catalog Number470
Company DUNS803114859
Company NameEqm Research, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com
Phone513-661-0560
Emailjpe@eqmresearch.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860010612224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DIHColorimetry, Cholinesterase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-08
Device Publish Date2023-07-31

Devices Manufactured by Eqm Research, Inc.

00860010612200 - Test-mate ChE Cholinesterase Test System2023-08-08 For the quantitative determination of Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnostic use.
00860010612217 - AChE Assay Kit2023-08-08 For the quantitative determination of Erythrocyte Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diag
00860010612224 - PChE Assay Kit2023-08-08For 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.
00860010612224 - PChE Assay Kit2023-08-08 For the quantitative determination of Plasma Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnosti
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