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ADVIA® Chemistry OP_2 Opiate_2 Reagents 10378763

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 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 Number00630414568799 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
ADVIA® Chemistry OP_2 Opiate_2 Reagents
Generic Name
Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
10378763
Description
Opiates - ADVIA Chem. - RGT - 4x190 tests
Primary DI / UDI-DI
00630414568799
510(k) Number
FDA Product Code
DJG
GMDN Term
Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
Device Class
Class II
Regulation Number
862.3650
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K971596)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

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