AccessGUDID - DEVICE: POINTE SCIENTIFIC ALBUMIN (00811727013385)

GUDID

Device Identifier (DI) Information

Brand Name: POINTE SCIENTIFIC ALBUMIN
Version or Model: 12-A7502-160
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12-A7502-160
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727013385
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: For the quantitative determination of Albumin in serum.

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?
59071	Albumin IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using a spectrophotometry method. It is typically used for the detection of small amounts of albumin in urine as an indicator of a kidney disease known as moderately increased albuminuria or microalbuminuria.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIX	Bromcresol Green Dye-Binding, Albumin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K822471	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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba1c63ee-0a05-40de-8773-fe9dfd6fc696
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: August 31, 2016