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Nucleic Acid Extraction and Purification Kit 1.0 Xvance 48C

by Sansure Biotech Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06955792702844 UDI-DIDate25 Mar 2026ListedStatusListed 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  • Withdrawn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
Nucleic Acid Extraction and Purification Kit 1.0
Generic Name
Nucleic acid extraction/isolation kit IVD
Model / Reference
Xvance 48C
Primary DI / UDI-DI
06955792702844
FDA Product Code
JJH
GMDN Term
Nucleic acid extraction/isolation kit IVD
Device Class
Class I
Regulation Number
862.2310
GUDID distribution status
In Commercial Distribution

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Properties

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

Other properties (7)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No