Skip to content

Affirm Vpiii Microbial Identification Test

by Microprobe Corp.

510(k) K931374

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 12 Oct 2026. What this means

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK931374 Date15 Jun 1993ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1394-2017 FDA Class II initiated 27 Aug 2015

    BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MLA
Device Class
Class I
Regulation
21 CFR Part 866.2660
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Other devices from Microprobe Corp.