Pointe Creatine Kinase for BS480 14-C7522-220

GUDID 00811727015785

Pointe Creatine Kinase packaged for use on the BS480. 4x40mL, 4x15mL Kit. For the quantitative determination of creatine kinase activity in serum. For in vitro diagnostic use only.

HORIBA INSTRUMENTS INCORPORATED

Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Primary Device ID00811727015785
NIH Device Record Key370dd4af-7eaa-4feb-bdd2-b9991e572066
Commercial Distribution StatusIn Commercial Distribution
Brand NamePointe Creatine Kinase for BS480
Version Model Number14-C7522-220
Catalog Number14-C7522-220
Company DUNS052845583
Company NameHORIBA INSTRUMENTS INCORPORATED
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@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
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
GS100811727015785 [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 Number2
Public Version Date2025-10-02
Device Publish Date2020-05-28

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