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Aptima® Kit, Calibrators, HIV Quant, Us IVD

by Hologic

Aptima® Kit, Calibrators, HIV Quant, Us IVD (PRD-03566) is a Class II device made by Hologic, listed under FDA premarket submission BK231025 and listed in FDA GUDID since 18 Jan 2017 (UDI-DI 15420045504226), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) BK231025

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15420045504226 UDI-DI Date18 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberBK231025 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA premarket submission BK231025 Active
  • FDA GUDID UDI-DI 15420045504226 listed 18 Jan 2017 Listed

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aptima®
Generic name
HIV1 nucleic acid IVD, calibrator
Model / Ref / Catalog
KIT, CALIBRATORS, HIV QUANT, US IVD, PRD-03566
Primary DI / UDI-DI
15420045504226
FDA product code
MZF
GMDN term
HIV1 nucleic acid IVD, calibrator
Device class
Class II
Regulation number
866.3956
GUDID distribution status
In Commercial Distribution

Related devices

Category: HIV1 nucleic acid IVD, calibrator

Cleared under the same submission (BK231025)

Cleared under the same submission (BP150318)

Other devices from Hologic

See all devices from Hologic →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)