AccessGUDID - DEVICE: ACCUHOME OVULATION (00695684755409)

GUDID

Device Identifier (DI) Information

Brand Name: ACCUHOME OVULATION
Version or Model: 75540
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GERMAINE LABORATORIES, INC

Primary DI Number: 00695684755409
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 40
Labeler D-U-N-S® Number*: 176458115 *Terms of Use

Device Description: Urine Midstream. Rapid qualitative test to detect the LH surge in urine. Designed to aid in the prediction of ovulation, for self testing (home).

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?
54255	Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of luteinizing hormone (LH) 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 used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEP	Radioimmunoassay, Luteinizing Hormone

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: 251bb233-c6d1-4cbe-b2f1-a2c63d9eadfd
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: April 27, 2016