AccessGUDID - DEVICE: AutoDELFIA Inhibin A kit Level Calibrators (06438147344406)

GUDID

Device Identifier (DI) Information

Brand Name: AutoDELFIA Inhibin A kit Level Calibrators
Version or Model: B064-112-P2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B064-112-P2
Company Name: Wallac Oy

Primary DI Number: 06438147344406
Issuing Agency: GS1
Commercial Distribution End Date: April 09, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 540156544 *Terms of Use

Device Description: Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.

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?
62325	Inhibin A IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative detection of inhibin A in a clinical specimen, using a fluorescent immunoassay method. Inhibin A detection is useful in studies of human reproductive physiology (e.g., as an endocrine marker for monitoring ovarian function).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDR	Enzyme Immunoassay, Inhibin-A

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 -80 and -60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e81e521d-de46-4249-a095-52db0b96269c
Public Version Date: June 12, 2025
Public Version Number: 2
DI Record Publish Date: November 21, 2018