FDA.reportPublic FDA data

ZHEJIANG GENE SCIENCE

Primary DI
06974679160201
Brand
ZHEJIANG GENE SCIENCE
Company
ZHEJIANG GENE SCIENCE CO., LTD.
Model
3.0 mL/tube;100pcs/Tray, 15 Trays/Box
Catalog number
YA-03
Device 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.
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
QBDMicrobial Nucleic Acid Storage And Stabilization Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBDMicrobial Nucleic Acid Storage And Stabilization DeviceMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212878000Sample preservation solutionZhejiang Gene Science Co., Ltd.2024-04-08QBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974679160201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974679160201069746791602016974679160201

GMDN Terms#

Term, Definition table
TermDefinition
Oral/upper respiratory tract specimen collection kitA 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.

Regulatory Flags#

DUNS number
415610563
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974679160768ZHEJIANG GENE SCIENCE2.0 mL/tube;100pcs/Tray, 15 Trays/BoxYA-022026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974679160768ZHEJIANG GENE SCIENCEZHEJIANG GENE SCIENCE CO., LTD.QBD2026-05-11
10850045030008Magbio Genomics, Inc.Magbio Genomics, Inc.QBD2026-03-27
00850049735490Magbio Genomics, Inc.Magbio Genomics, Inc.QBD2026-03-27
00850045030018Magbio Genomics, Inc.Magbio Genomics, Inc.QBD2026-03-27
B9030201PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2025-11-03
B9030315PrimeStore MTM Longhorn Vaccines And Diagnostics, LLCQBD2025-11-03
07898996204648Molecular Transport Media (MTM) 2mlA. L. B. LUZQBD2024-08-29
07898996204655Molecular Transport Media (MTM) 3mlA. L. B. LUZQBD2024-08-29
05411967003464InActiv BlueFertipro NVQBD2024-08-14
05411967003471InActiv BlueFertipro NVQBD2024-08-14
06973843228914Sample Preservative FluidHangzhou Bioer Technology Co., Ltd.QBD2024-07-15
16973471968784DTPMShenzhen Dakewe Bio-engineering Co., LtdQBD2024-06-07
26973471968781DTPMShenzhen Dakewe Bio-engineering Co., LtdQBD2024-06-07
06973471968763DTPMShenzhen Dakewe Bio-engineering Co., LtdQBD2024-05-20
B90305154PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-03-20
B9030515500PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-03-20
B90305153PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-27
B90305151000PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-27
B90312023PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-09
B90312033PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-09
B90305151PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B90312022PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B90312032PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B903051550PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B90312002100PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B9031203100PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
06973471968503BioSci™Shenzhen Dakewe Bio-engineering Co., LtdQBD2024-02-01
06973471968510BioSci™Shenzhen Dakewe Bio-engineering Co., LtdQBD2024-02-01
06973471968527BioSci™Shenzhen Dakewe Bio-engineering Co., LtdQBD2024-02-01
00860011194507DNA/RNA Shield™ SafeCollect Saliva Collection KitBlue Life Solutions, LLCQBD2024-01-01