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VERSANT® Sample Preparation 1.2 Reagents (Box 1) 10629800

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 Number00630414587134 UDI-DI Date24 Sep 2018ListedStatusListed 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  • Withdrawn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® Sample Preparation 1.2 Reagents (Box 1)
Generic Name
Nucleic acid extraction/isolation kit IVD
Model / Ref / Catalog
10629800
Primary DI / UDI-DI
00630414587134
FDA Product Code
JJH
GMDN Term
Nucleic acid extraction/isolation kit IVD
Device Class
Class I
Regulation Number
862.2310
GUDID distribution status
Not in Commercial Distribution

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • 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
  • Serial Number: No
  • Manufacturing Date: No