AccessGUDID - DEVICE: Micro-albumin ELISA (00404847438819)

GUDID

Device Identifier (DI) Information

Brand Name: Micro-albumin ELISA
Version or Model: EIA-3881
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EIA-3881
Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung

Primary DI Number: 00404847438819
Issuing Agency: GS1
Commercial Distribution End Date: November 20, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 317134468 *Terms of Use

Device Description: Micro-Albumin ELISA is a competitive test system for the quantitative measurement of human albumin in urine.

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):	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?
53476	Microalbumin IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of microalbumin in a clinical specimen, using a spectrophotometry method.	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
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: 196db69e-5fd2-4c24-90b6-7b64c2f4e224
Public Version Date: November 21, 2024
Public Version Number: 3
DI Record Publish Date: June 07, 2021