Babio

Primary DI
06975025173814
Brand
Babio
Company
Jinan Babio Biotechnology Co., Ltd.
Model
VTM
Device description
Babio® Virus Transport Kit (Non-inactivated) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. It measures viral particles in the samples using molecular or antigen assays. Not intended for internal use.
Published
2023-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
06975025173814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975025173814069750251738146975025173814

GMDN Terms#

Term, Definition table
TermDefinition
Cytology specimen container IVD, transport bufferA covered receptacle containing transport buffer solution intended to be used for the collection, preservation, and transport of a cytology specimen (e.g., oral, cervical, colonic) for in vitro diagnostic investigation [e.g., histopathological cervical cancer screening]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527015617
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975025179250Babio50 Tests, 3 mL Babio® VTM tubes, One Nasal Swab(N12026-01-27
06975025179267Babio50 Tests, 3 mL Babio® VTM tubes, One Throat Swab(T2026-01-27
06975025179274Babio50 Tests, 3 mL Babio® VTM tubes, One Throat Swab(T2026-01-27
06975025179281Babio50 Tests, 3 mL Babio® VTM tubes, One Nasal Swab(N12026-01-27
06975025179298Babio50 Tests,3 mL Babio® VTM tubes,One Nasal Swab (N152026-01-27
06975025179304Babio600 Tests, 3 mL Babio® VTM tubes, One Nasal Swab(N2026-01-27
06975025177478Babio2ml/tube,50pieces/pack2025-09-29
06975025173852BabioVTM2023-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975025173852BabioJinan Babio Biotechnology Co., Ltd.QMC2023-02-14
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
06973471960705Biosci™Shenzhen Dakewe Bio-engineering Co., LtdQMC2022-12-08
00816576024575N/AHARDY DIAGNOSTICSQMC2022-01-25
00816576024537N/AHARDY DIAGNOSTICSQMC2022-01-25