ClearChem Diagnostics Inc. Creatine Kinase (CK) CPK1110

GUDID 00852169008089

In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL

CLEARCHEM DIAGNOSTICS INC.

Total creatine kinase (CK) IVD, reagent
Primary Device ID00852169008089
NIH Device Record Keycbc2a7e9-2802-4757-93ec-38f70eb09a5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearChem Diagnostics Inc. Creatine Kinase (CK)
Version Model NumberCPK1110
Catalog NumberCPK1110
Company DUNS010655581
Company NameCLEARCHEM DIAGNOSTICS INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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

Phone+1(714)734-8041
Emaildwheat@clearchem.net

Device Dimensions

Total Volume225 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Refrigerated
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Refrigerated

Device Identifiers

Device Issuing AgencyDevice ID
GS100852169008089 [Primary]

FDA Product Code

CGSNAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-31
Device Publish Date2018-04-30

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