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X-Lysa Flex System X-Lysa Flex (US)

by Sansure Biotech Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06955792702622 UDI-DIDate12 Jun 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  • Withdrawn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
X-Lysa Flex System
Generic Name
Nucleic acid sample preparation instrument IVD
Model / Reference
X-Lysa Flex (US)
Primary DI / UDI-DI
06955792702622
FDA Product Code
JJH
GMDN Term
Nucleic acid sample preparation instrument IVD
Device Class
Class I
Regulation Number
862.2310
GUDID distribution status
In Commercial Distribution

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Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • 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