FDA.reportPublic FDA data

ThermoQ

Primary DI
06973843221069
Brand
ThermoQ
Company
Hangzhou Bioer Technology Co., Ltd.
Model
CHB-T2-C
Device description
For the detail information, please refer to the IFU.
Published
2025-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JRGBlock, Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRGBlock, HeatingClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973843221069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973843221069069738432210696973843221069

GMDN Terms#

Term, Definition table
TermDefinition
Heating block IVDAn electrically-powered device which is primarily a heating element, with or without a thermostat, that is built into a compact block and intended to be used as a stable dry heat source to heat in vitro diagnostic specimens/laboratory materials. It is typically a stand-alone instrument, or an interchangeable component of an in vitro diagnostic instrument/analyser. It is available in various sizes to accommodate microplates of varying sizes, and may include covers to minimize evaporation from microplates.

Sterilization Methods#

Method table
Method

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973843220871Thermo Cell Mixing Block Hangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220888Thermo Shaker Mixing Block Hangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220895ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220901ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220918ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220925ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220932ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220949ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220956ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220963ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220970ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220987ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220994ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221007ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221014ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221021ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221038ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221052ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221076ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221083ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221120Thermo CellHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221137Thermo CellHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221144ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06936895301318BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
06936895301325BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
06936895301332BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
06936895301349BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
09349458005443ThermoBrite Elite InstrumentLEICA BIOSYSTEMS MELBOURNE PTY LTDJRG2022-07-18
00815236020926HemoTemp II ActivatorLCR HALLCREST, LLC.JRG2022-06-16
10815236020923HemoTemp II ActivatorLCR HALLCREST, LLC.JRG2022-06-16