Skip to content

ZHEJIANG GENE SCIENCE 2.0 mL/tube;100pcs/Tray, 15 Trays/Box

by Zhejiang Gene Science Co., Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06974679160768 UDI-DIDate11 May 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  • Withdrawn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
Zhejiang Gene Science
Generic Name
Oral/upper respiratory tract specimen collection kit
Model / Ref / Catalog
2.0 mL/tube, 100pcs/Tray, 15 Trays/Box, YA-02
Primary DI / UDI-DI
06974679160768
510(k) Number
FDA Product Code
QBD
GMDN Term
Oral/upper respiratory tract specimen collection kit
Models / Variants
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