Biosci™

Primary DI
06973471960705
Brand
Biosci™
Company
Shenzhen Dakewe Bio-engineering Co., Ltd
Model
MSB
Device description
3 ml of 0.85% Biosci™ Sterile Normal Saline in screw-cap tube, with nasopharyngeal swab.
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QMCTransport Medium, Notified Per The Vtm Guidance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMCTransport Medium, Notified Per The Vtm GuidanceMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973471960705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973471960705069734719607056973471960705

GMDN Terms#

Term, Definition table
TermDefinition
General tissue specimen container IVD, fixative/salineA covered receptacle (single- or multiple-compartment) containing a tissue fixation or preservation solution [e.g., formalin, saline] intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain patient-contact tissue specimen sampling/excision devices. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543029175
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing 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
06975025173852BabioJinan Babio Biotechnology Co., Ltd.QMC2023-02-14
06975025173814BabioJinan Babio Biotechnology Co., Ltd.QMC2023-02-02
06973471960699Biosci™Shenzhen Dakewe Bio-engineering Co., LtdQMC2022-12-08
06973471960712Biosci™Shenzhen Dakewe Bio-engineering Co., LtdQMC2022-12-08
06973471960729SNT BiotechShenzhen Dakewe Bio-engineering Co., LtdQMC2022-12-08
06973471960736SNT BiotechShenzhen Dakewe Bio-engineering Co., LtdQMC2022-12-08
00816576024575N/AHARDY DIAGNOSTICSQMC2022-01-25
00816576024537N/AHARDY DIAGNOSTICSQMC2022-01-25