Device
The Zhejiang GENE SCIENCE Co., Ltd. Sample Preservation Solution consists of a plastic, polypropylene screw-cap collection tube filled with non-sterile sample preservation medium....
Manufacturer
ZHEJIANG GENE SCIENCE CO., LTD.
ZHEJIANG GENE SCIENCE CO., LTD.
Model: 2.0 mL/tube;100pcs/Tray, 15 Trays/Box
Catalog: YA-02
DI: 06974679160768
Status: New
MRI: MR Safe
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
The Zhejiang GENE SCIENCE Co., Ltd. Sample Preservation Solution consists of a plastic, polypropylene screw-cap collection tube filled with non-sterile sample preservation medium. The tubes are pre-filled with either 2 mL (suitable for swabs with flocking length of 20-24mm) or 3 mL (suitable for swabs with flocking length of 24-30mm) of solution. The device is non-sterile, singe use.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4aba14bc-7422-45c1-9ea6-4facfcc2f41f
Distribution Status:
In Commercial Distribution
DUNS Number:
415610563
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
06974679160768
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61164
Name: Oral/upper respiratory tract specimen collection kit
Definition:
A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.
FDA Product Codes
QBD
Microbial Nucleic Acid Storage And Stabilization Device
Premarket Submissions
Submission Number:
K212878
Supplement Number:
000