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N/A R21

by Hardy Diagnostics FDA registration: United States GUDID

Product code JSI

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00819398023214 UDI-DIDate4 Jun 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
Differential/selective agar culture medium IVD
Model / Ref / Catalog
R21
Description
BiGGY Agar Slant (Nickerson's Agar), for Candida, 3ml, 13x100mm tube, order by the package of 20 For the selective isolation and identification of Candida spp.
Primary DI / UDI-DI
00819398023214
FDA Product Code
JSI
GMDN Term
Differential/selective agar culture medium IVD
Device Class
Class I
Regulation Number
866.2360
Commercial Distribution
In Commercial Distribution

Related devices

Category: Differential/selective agar culture medium IVD

Other devices from Hardy Diagnostics

See all devices from Hardy Diagnostics →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI 0bcccc28-f346-4c8a-a304-bd5be87a56c9 36 fields · synced 24 Oct 2026