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BioSieve 01

by Vivachek Biotech (Hangzhou) Co., Ltd. 2 variants

Listed FDA GUDID listing, no authorization on record

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 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06937339211538 UDI-DI Date14 Oct 2026ListedStatusListed GUDID: 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  • Withdrawn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
BioSieve
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
01, VDMD-1194-002
Primary DI / UDI-DI
06937339211538
FDA Product Code
NGL, NFY, NFT, PTH, NFV, PTG, NGG, LCM, QBF, QAW, NFW
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3650, 862.3250, 862.3100, 862.3150, 862.3170, 862.3620, 862.3610, 862.3700, 862.3910, 862.3870
GUDID distribution status
In Commercial Distribution

Other devices from Vivachek Biotech (Hangzhou) Co., Ltd.

See all devices from Vivachek Biotech (Hangzhou) Co., Ltd. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No