AccessGUDID - DEVICE: Clearblue (00633472602245)

GUDID

Device Identifier (DI) Information

Brand Name: Clearblue
Version or Model: Menopause Stage Indicator
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: SPD SWISS PRECISION DIAGNOSTICS GMBH

Primary DI Number: 00633472602245
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 483609579 *Terms of Use

Device Description: CB Menopause Stage Indicator 5ct US

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:	No
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
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 94eb3d1a-994d-4827-8da3-624dbeb70b43
Public Version Date: August 08, 2023
Public Version Number: 1
DI Record Publish Date: July 31, 2023