AccessGUDID - DEVICE: Galactose (with Membrane Plate) ELISA (00840239014863)

GUDID

Device Identifier (DI) Information

Brand Name: Galactose (with Membrane Plate) ELISA
Version or Model: EIA-1486
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EIA-1486
Company Name: DRG International Inc

Primary DI Number: 00840239014863
Issuing Agency: GS1
Commercial Distribution End Date: July 19, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: The DRG Galactose kit is designed for the quantitative determination of galactose in neonatal blood spots. It is for in-vitro diagnostic use as an aid in screening newborns for the elevated galactose levels as seen in galactosemia.

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?
59376	Total galactose IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total galactose (galactose and galactose-1-phosphate) in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIA	ENZYMATIC METHODS, GALACTOSE

FDA Premarket Submission

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

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: 592a9eb2-1e55-4ed4-a094-7563bc96d924
Public Version Date: July 26, 2023
Public Version Number: 3
DI Record Publish Date: June 07, 2021