FDA.reportPublic FDA data

BIOER LineGene 9600 Plus Fluorescent Quantitative Detection System

Primary DI
06973843220543
Brand
BIOER LineGene 9600 Plus Fluorescent Quantitative Detection System
Company
Hangzhou Bioer Technology Co., Ltd.
Model
FQD-96A(EA5)
Device description
For the detail information, please refer to the IFU.
Published
2023-01-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973843220543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973843220543069738432205436973843220543

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or quantified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.

Regulatory Flags#

DUNS number
545256935
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973843220277BIOER GeneExplorer Thermal CyclerGE-96G2023-01-11
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
06973843220482BIOER GeneExplorer Thermal CyclerGE-96S2023-01-11
06973843220499BIOER GeneExplorer Thermal CyclerGE-48DG2023-01-11
06973843220505BIOER LineGene MiniS Fluorescent Quantitative Detection SystemFQD-16B(EA2)2023-01-11
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
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
06973843220895ThermoQHB-T1-A2025-02-11

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