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ZHEJIANG GENE SCIENCE 3.0 mL/tube - 100pcs/Tray, 15 Trays/Box

by Zhejiang Gene Science Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06974679160201 UDI-DI Date11 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Zhejiang Gene Science
Generic Name
Oral/upper respiratory tract specimen collection kit
Model / Ref / Catalog
3.0 mL/tube, 100pcs/Tray, 15 Trays/Box, YA-03
Primary DI / UDI-DI
06974679160201
510(k) Number
FDA Product Code
QBD
GMDN Term
Oral/upper respiratory tract specimen collection kit
Models / Variants
100pcs/Tray, 15 Trays/Box
Device Class
Class II
Regulation Number
866.2950
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K212878)

Other devices from Zhejiang Gene Science Co., Ltd.

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