AccessGUDID - DEVICE: Men's Rapid Fertility Test (00860001286533)

GUDID

Device Identifier (DI) Information

Brand Name: Men's Rapid Fertility Test
Version or Model: TQK-0-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTOX DIAGNOSTICS, INC.

Primary DI Number: 00860001286533
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118569262 *Terms of Use

Device Description: Men's Rapid Fertility Test, QC Kit

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:	No
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?
61072	Sperm concentration indicator IVD, kit, rapid colorimetric, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative determination of sperm concentration in a semen specimen within a short period of time relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment, as an indicator of male fertility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
POV	Semen Analysis Device

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d106a9aa-84fd-4464-a5cb-e53da07b8d7f
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: July 26, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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