Chemistry 3 Install Verifier Kit

GUDID 00852553007292

Calibration Verifier

VERICHEM LABORATORIES, INC.

Multiple clinical chemistry protein IVD, calibrator
Primary Device ID00852553007292
NIH Device Record Keyac3d945e-42e1-452c-b4e3-c21d8c4e7e51
Commercial Distribution StatusIn Commercial Distribution
Brand NameChemistry 3 Install Verifier Kit
Version Model Number9820
Company DUNS189023351
Company NameVERICHEM LABORATORIES, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-552-5859
Emailcustomerservice@verichemlabs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852553007292 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JIXCalibrator, Multi-Analyte Mixture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-17

Devices Manufactured by VERICHEM LABORATORIES, INC.

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00852553007070 - Bilirubin Standard, Level F2018-07-06 Calibrator / Calibration Verifier

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