AccessGUDID - DEVICE: Micro-Albumin (00198168683255)

GUDID

Device Identifier (DI) Information

Brand Name: Micro-Albumin
Version or Model: ORG 5MA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ORG 5MA
Company Name: ORGENTEC Diagnostika GmbH

Primary DI Number: 00198168683255
Issuing Agency: GS1
Commercial Distribution End Date: October 11, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 328133103 *Terms of Use

Device Description: Micro-Albumin is a competitive ELISA test system for the quantitative measurement of human albumin in urine. This product is intended for professional in vitro diagnostic use only. The rate of albumin excertion in urine is an important control and prevention parameter for the evaluation of kidney function. If the glomerular filtration process is highly active, albumin excretion may be elevated without any kidney damage. Physical stress may also cause microalbuminuria.

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:	Yes
Prescription Use (Rx):	No
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?
53598	Albumin IVD, kit, enzyme immunoassay (EIA)	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 an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis and monitoring of diseases affecting protein metabolism (e.g., liver disease, kidney disease, severe malnutrition, malabsorption, burns).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2657c810-19e6-478d-8359-095cf8117826
Public Version Date: August 18, 2025
Public Version Number: 3
DI Record Publish Date: December 14, 2023