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N/A Z75

by Hardy Diagnostics FDA registration: United States GUDID

Product code JTO

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00819398027304 UDI-DIDate10 Aug 2020ListedStatusIn distribution

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Specification

GUDID · synced 24 Oct 2026

Trade Name
N/A
Generic Name
Pyrrolidonyl arylamidase (PYR) activity IVD, kit, rapid colorimetric, clinical
Model / Ref / Catalog
Z75
Primary DI / UDI-DI
00819398027304
FDA Product Code
JTO
GMDN Term
Pyrrolidonyl arylamidase (PYR) activity IVD, kit, rapid colorimetric, clinical
Device Class
Class I
Regulation Number
866.2660
Commercial Distribution
In Commercial Distribution

Related devices

Category: Pyrrolidonyl arylamidase (PYR) activity IVD, kit, rapid colorimetric, clinical

Other devices from Hardy Diagnostics

See all devices from Hardy Diagnostics →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
Other properties (9)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI eb5422f5-ccc1-4e4a-8be5-00d12c67c890 36 fields · synced 24 Oct 2026