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IDS-iSYS Free Testosterone Calibration Verifiers IS-5335

by Immunodiagnostic Systems, Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060169691254 UDI-DIDate3 Nov 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
IDS-iSYS Free Testosterone Calibration Verifiers
Generic Name
Free testosterone IVD, calibrator
Model / Reference
IS-5335
Primary DI / UDI-DI
05060169691254
FDA Product Code
JJX
GMDN Term
Free testosterone IVD, calibrator
Device Class
Class I
Regulation Number
862.1660
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

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Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

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