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Onclarity™ Self-Collection Kit-Viper™ LT 445445

by Becton, Dickinson and Company

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 26 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00382904454456 UDI-DI Date17 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Onclarity™ Self-Collection Kit-Viper™ LT
Generic Name
Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use
Model / Ref / Catalog
445445
Primary DI / UDI-DI
00382904454456
510(k) Number
FDA Product Code
SEP
GMDN Term
Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use
Device Class
Class II
Regulation Number
866.2920
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K260184)

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Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No