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VERSANT® HCV RNA 3.0 ASSAY bDNA 10333499

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00630414472386 UDI-DI Date24 Sep 2014ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
VERSANT® HCV RNA 3.0 ASSAY bDNA
Generic Name
Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
10333499, 2553870
Primary DI / UDI-DI
00630414472386
FDA Product Code
MZP
GMDN Term
Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Device Class
Class II
Regulation Number
866.3170
GUDID distribution status
Not in Commercial Distribution

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Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: 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