FDA.reportPublic FDA data

BIOER Viral Transport Medium

Primary DI
06973843228396
Brand
BIOER Viral Transport Medium
Company
Hangzhou Bioer Technology Co., Ltd.
Model
BSC85L1
Device description
For the detail information, please refer to the IFU.
Published
2023-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JSMCulture Media, Non-Propagating Transport

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSMCulture Media, Non-Propagating TransportMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973843228396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973843228396069738432283966973843228396

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, additive/mediumA covered receptacle containing an additive and/or medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)] intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Regulatory Flags#

DUNS number
545256935
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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06973843220376BIOER GeneExplorer Thermal CyclerGE-48DS2023-01-11
06973843220383BIOER GeneExplorer Thermal CyclerGE-384G2023-01-11
06973843220390BIOER GeneExplorer Thermal CyclerGE-4I2023-01-11
06973843220420BIOER GeneExplorer Thermal CyclerGE-48D2023-01-11
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06973843220499BIOER GeneExplorer Thermal CyclerGE-48DG2023-01-11
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06973843220512BIOER LineGene MiniS Fluorescent Quantitative Detection SystemFQD-16B(EA4)2023-01-11
06973843220529BIOER LineGene 9600 Plus Fluorescent Quantitative Detection SystemFQD-96A(EA2)2023-01-11
06973843220536BIOER LineGene 9600 Plus Fluorescent Quantitative Detection SystemFQD-96A(EA4)2023-01-11
06973843220543BIOER LineGene 9600 Plus Fluorescent Quantitative Detection SystemFQD-96A(EA5)2023-01-11
06973843220550BIOER LineGene 9600 Plus Fluorescent Quantitative Detection SystemFQD-96A(EA6)2023-01-11
06973843220567BIOER QuantGene 9600 Fluorescent Quantitative Detection SystemFQD-96C(EA4)2023-01-11
06973843220574BIOER QuantGene 9600 Fluorescent Quantitative Detection SystemFQD-96C(EA5)2023-01-11
06973843220581BIOER QuantGene 9600 Fluorescent Quantitative Detection SystemFQD-96C(EA6)2023-01-11
06973843220802careSTART™ Q1 AmplifierTQA-E001822025-02-11
06973843220864GenePure Pro 16H Nucleic Acid Purification SystemNPA-16H2025-02-11
06973843220871Thermo Cell Mixing Block MB-1012025-02-11
06973843220888Thermo Shaker Mixing Block MB-2022025-02-11

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