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Syva® Emit® II 5B3 THC Assay 10445468

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842768023910 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Syva® Emit® II 5B3 THC Assay
Generic Name
Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
10445468, 9M979UL
Primary DI / UDI-DI
00842768023910
510(k) Number
FDA Product Code
LDJ
GMDN Term
Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Device Class
Class II
Regulation Number
862.3870
GUDID distribution status
Not in Commercial Distribution

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Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

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