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MobiLab Standard Sexual Health Self Rapid Test MSSH

by MobiLab Medical Innovatives Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860008737304 UDI-DI Date5 Feb 2024ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MobiLab Standard Sexual Health Self Rapid Test
Generic Name
Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use
Model / Reference
MSSH
Primary DI / UDI-DI
00860008737304
FDA Product Code
JXA
GMDN Term
Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use
Device Class
Class I
Regulation Number
866.2660
GUDID distribution status
Not in Commercial Distribution

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No