FDA.reportPublic FDA data

Dakewe

Primary DI
06973471960514
Brand
Dakewe
Company
Shenzhen Dakewe Bio-engineering Co., Ltd
Model
ITMM
Catalog number
3983021
Device description
2 mL of Inactivated Transport Medium in screw-cap tube. 50 tests per package.
Published
2023-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K220059000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220059000Biosci™ Inactivated Transport Medium, Biosci™ ITMShenzhen Dakewe Bio-Engineering Co., Ltd.2023-01-19QBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973471960511PackageGS112In Commercial Distribution
06973471960514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697347196051116973471960511
06973471960514069734719605146973471960514

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543029175
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16973471962171BioSciON2026-05-08
16973471962188BioSciON2026-05-08
16973471962195BioSciOO2026-05-08
16973471962201BioSciOO2026-05-08
16973471962218BioSciONO2026-05-08
16973471962225BioSciONO2026-05-08
16973471962232BioSciOM2026-05-08
16973471962249BioSciOM2026-05-08
16973471962256BioSciOM2026-05-08
16973471962263BioSciOM2026-05-08
16977644780029BioSci™VO69913212024-08-30
16977644780036BioSci™VNO69911912024-08-30
16977644780043BioSci™VNO69913912024-08-30
26977644780026BioSci™VO69913212024-08-30
26977644780033BioSci™VNO69911912024-08-30
26977644780040BioSci™VNO69913912024-08-30
16977644780012BioSci™VO69911212024-08-12
26977644780019BioSci™VO69911212024-08-12
16973471969941BioSci™VM69910142024-07-23
16973471969996BioSci™VN69911112024-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00609576901911PurSafe+Puritan Medical ProductsQBD2026-07-08
00609576901928PurSafe+Puritan Medical ProductsQBD2026-07-08
00609576901935PurSafe+Puritan Medical ProductsQBD2026-07-08
06974679160201ZHEJIANG GENE SCIENCEZHEJIANG GENE SCIENCE CO., LTD.QBD2026-05-11
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