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PermaQuick 634

by Ultradent Products, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00883205103680 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PermaQuick
Generic Name
HIV1 antibody IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
634
Primary DI / UDI-DI
00883205103680
510(k) Number
FDA Product Code
KLE
GMDN Term
HIV1 antibody IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
872.3200
GUDID distribution status
In Commercial Distribution

Related devices

Category: HIV1 antibody IVD, kit, rapid ICT, clinical

Cleared under the same submission (K951867)

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

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