AccessGUDID - DEVICE: Follicle Stimulating Hormone (FSH) ELISA (00840239017857)

GUDID

Device Identifier (DI) Information

Brand Name: Follicle Stimulating Hormone (FSH) ELISA
Version or Model: EIA-1785
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EIA-1785
Company Name: DRG International Inc

Primary DI Number: 00840239017857
Issuing Agency: GS1
Commercial Distribution End Date: August 16, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: The FSH ELISA is intended for the quantitative determination of FSH concentration in human serum. The assay is useful in the diagnosis and treatment of pituitary and gonadal disorders.

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?
54186	Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of follicle stimulating hormone (FSH) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NGA	TEST, FOLLICLE STIMULATING HORMONE (FSH), OVER THE COUNTER

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: b89e45a3-cf60-4a3a-821f-81a685a11acf
Public Version Date: July 26, 2023
Public Version Number: 2
DI Record Publish Date: June 09, 2021