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Aptima® APTIMA GPRS, 250 TESTS (REF)

by Hologic

Aptima® APTIMA GPRS, 250 TESTS (REF) (302071) is a Class I device made by Hologic, listed in FDA GUDID since 2 May 2016 (UDI-DI 15420045506442), 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 Number15420045506442 UDI-DI Date2 May 2016ListedStatusListed 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  • Withdrawn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
Aptima®
Generic name
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
APTIMA GPRS, 250 TESTS (REF), 302071
Primary DI / UDI-DI
15420045506442
FDA product code
PPM
GMDN term
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Device class
Class I
Regulation number
864.4010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Other devices from Hologic

See all devices from Hologic →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)