AccessGUDID - DEVICE: MEIJER OVULATION TEST - EASY ONE STEP (00760236169192)

GUDID

Device Identifier (DI) Information

Brand Name: MEIJER OVULATION TEST - EASY ONE STEP
Version or Model: 16919
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEIJER, INC.

Primary DI Number: 00760236169192
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 7
Labeler D-U-N-S® Number*: 006959555 *Terms of Use

Device Description: One-step ovulation predictor test used for the detection of Luteininzing Hormone (LH) in urine to predict your time of ovulation.

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):	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?
54254	Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of luteinizing hormone (LH) in a clinical specimen, using a chemiluminescent immunoassay method.	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: No 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 59 and 83 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0cb7c7da-c207-4a14-85be-5532849e7a1e
Public Version Date: July 18, 2018
Public Version Number: 4
DI Record Publish Date: July 22, 2016