AccessGUDID - DEVICE: Proov (00850035206058)

GUDID

Device Identifier (DI) Information

Brand Name: Proov
Version or Model: Reserve
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mfb Fertility, Inc.

Primary DI Number: 00850035206058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080270263 *Terms of Use

Device Description: At home IVD FSH test to measure follicle stimulating hormone and check your ovarian reserve status.

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):	Yes
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?
65841	Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of follicle stimulating hormone (FSH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment as an aid in the diagnosis of conditions related to reproductive health (e.g., menopause, infertility).	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3c1d6508-b050-4c1b-b7d9-60aa3f0407f4
Public Version Date: April 25, 2023
Public Version Number: 1
DI Record Publish Date: April 17, 2023