AccessGUDID - DEVICE: Pointe Scientific (00811727012555)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Scientific
Version or Model: HA961-610
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HA961-610
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727012555
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: AST Reagent Set for the quantitative determination of Aspartate Aminotransferase (AST) in human serum. Packaged at 5 x 100ml, 2 x 55ml

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?
52953	Aspartate aminotransferase (AST) isoenzyme IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple aspartate aminotransferase (AST) isoenzymes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K813405	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: b766b3dc-b90f-4f2f-b849-6ee0d7009c65
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016