AccessGUDID - DEVICE: POINTE SCIENTIFIC CK-MB (00811727010964)

GUDID

Device Identifier (DI) Information

Brand Name: POINTE SCIENTIFIC CK-MB
Version or Model: C7562-150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C7562-150
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727010964
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: The CK-MB Reagent is for the quantitative determination of the isoenzyme Creatine Kinase-MB (CK-MB) in serum. For in vitro diagnostic use only.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52994	Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JHW	U.V. Method, Cpk Isoenzymes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K942958	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fc43391c-5283-43a6-bc02-2ef39a21d228
Public Version Date: July 06, 2023
Public Version Number: 4
DI Record Publish Date: August 31, 2016