Pointe Scientific, Inc. CK HC922-300

GUDID 00811727012999

CK Reagent is for the quantitative determination of creatine kinase activity in serum on Hitachi analyzers.

POINTE SCIENTIFIC, INC.

Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Primary Device ID00811727012999
NIH Device Record Keyf8309429-d3c6-4fb4-b4d6-b8ee62cac89c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePointe Scientific, Inc. CK
Version Model NumberHC922-300
Catalog NumberHC922-300
Company DUNS045623154
Company NamePOINTE SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100811727012999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

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 Date2016-08-31

On-Brand Devices [Pointe Scientific, Inc. CK]

00811727014696CK Reagent, for the quantitative determination of creatine kinase activity in serum. Size: 1 x 1
00811727012999CK Reagent is for the quantitative determination of creatine kinase activity in serum on Hitachi

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