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Accutest H. Pylori Urease Rapid Test ID750

by Jant Pharmacal Corp.

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 Number10763924750044 UDI-DI Date21 Apr 2026ListedStatusListed 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  • Withdrawn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
Accutest H. Pylori Urease Rapid Test
Generic Name
Helicobacter pylori urease IVD, kit, chromogenic
Model / Reference
ID750
Primary DI / UDI-DI
10763924750044
510(k) Number
FDA Product Code
LYR
GMDN Term
Helicobacter pylori urease IVD, kit, chromogenic
Device Class
Class I
Regulation Number
866.3110
GUDID distribution status
In Commercial Distribution
Size
Weight — 0.6 Pound
Length — 5.75 Inch
Width — 3 Inch
Height — 2.25 Inch

Related devices

Cleared under the same submission (K052708)

Other devices from Jant Pharmacal Corp.

See all devices from Jant Pharmacal Corp. →

Properties

  • Single Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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