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OSOM BV Blue Control Kit 184

by Sekisui Diagnostics, LLC

OSOM BV Blue Control Kit 184 is a Class I device made by Sekisui Diagnostics, LLC, listed in FDA GUDID since 29 Dec 2025 (UDI-DI 00742860100062), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00742860100062 UDI-DI Date29 Dec 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
OSOM BV Blue Control Kit
Generic name
Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
Model / Ref / Catalog
184
Primary DI / UDI-DI
00742860100062
FDA product code
JTR
GMDN term
Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
Device class
Class I
Regulation number
866.2480
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code JTR (Kit, Quality Control For Culture Media).

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Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)