FDA.reportPublic FDA data

Biomeme Franklin three9 Real-Time PCR Thermocycler

Primary DI
00810096640017
Brand
Biomeme Franklin three9 Real-Time PCR Thermocycler
Company
Biomeme, Inc.
Model
2.9
Catalog number
1000003
Device description
Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells.
Published
2022-12-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QJRReagents, 2019-Novel Coronavirus Nucleic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJRReagents, 2019-Novel Coronavirus Nucleic AcidUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810096640017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810096640017008100966400178100966400170810096640017

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 identified 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2679307707support@biomeme.com

Regulatory Flags#

DUNS number
079110357
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
00810096640031Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0130005362022-12-02
00810096640048Biomeme SARS-CoV-2 Go-Strips Kit130005552022-12-02
00810096640055Biomeme SARS-CoV-2 Go-Strips130006332022-12-02
00810096640062Biomeme Void Filling Caps130005202022-12-02
00810096640079Biomeme RNA Process Control (RPC) Kiit130006272022-12-02
00810096640086Biomeme SARS-CoV-2 Go-Plates Kit130005622022-12-02
00810096640093Biomeme SARS-CoV-2 Go-Plates130006342022-12-02
00810096640109Biomeme DNA/RNA Preservation Buffer (100/pk)130005772022-12-02
00810096640024Biomeme Franklin three9 Real-Time PCR Thermocycler2.910000182022-12-02
00810096640116Biomeme Franklin three9 Real-Time PCR Thermocycler2.810000032022-12-02
00810096640123Biomeme Franklin three9 Real-Time PCR Thermocycler2.810000182022-12-02
00810096640130Biomeme GoDx App for US2.3.52022-12-02
10810096640038Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0130005362022-12-02
10810096640045Biomeme SARS-CoV-2 Go-Strips Kit130005552022-12-02
10810096640052Biomeme SARS-CoV-2 Go-Strips130006332022-12-02
10810096640069Biomeme Void Filling Caps130005202022-12-02
10810096640076Biomeme RNA Process Control (RPC) Kiit130006272022-12-02
10810096640083Biomeme SARS-CoV-2 Go-Plates Kit130005622022-12-02
10810096640090Biomeme SARS-CoV-2 Go-Plates130006342022-12-02
10810096640106Biomeme DNA/RNA Preservation Buffer (100/pk)130005772022-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810096640031Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0Biomeme, Inc.QJR2022-12-02
00810096640048Biomeme SARS-CoV-2 Go-Strips KitBiomeme, Inc.QJR2022-12-02
00810096640055Biomeme SARS-CoV-2 Go-StripsBiomeme, Inc.QJR2022-12-02
00810096640062Biomeme Void Filling CapsBiomeme, Inc.QJR2022-12-02
00810096640079Biomeme RNA Process Control (RPC) KiitBiomeme, Inc.QJR2022-12-02
00810096640086Biomeme SARS-CoV-2 Go-Plates KitBiomeme, Inc.QJR2022-12-02
00810096640093Biomeme SARS-CoV-2 Go-PlatesBiomeme, Inc.QJR2022-12-02
00810096640109Biomeme DNA/RNA Preservation Buffer (100/pk)Biomeme, Inc.QJR2022-12-02
00810096640024Biomeme Franklin three9 Real-Time PCR ThermocyclerBiomeme, Inc.QJR2022-12-02
10810096640038Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0Biomeme, Inc.QJR2022-12-02
10810096640045Biomeme SARS-CoV-2 Go-Strips KitBiomeme, Inc.QJR2022-12-02
10810096640052Biomeme SARS-CoV-2 Go-StripsBiomeme, Inc.QJR2022-12-02
10810096640069Biomeme Void Filling CapsBiomeme, Inc.QJR2022-12-02
10810096640076Biomeme RNA Process Control (RPC) KiitBiomeme, Inc.QJR2022-12-02
10810096640083Biomeme SARS-CoV-2 Go-Plates KitBiomeme, Inc.QJR2022-12-02
10810096640090Biomeme SARS-CoV-2 Go-PlatesBiomeme, Inc.QJR2022-12-02
10810096640106Biomeme DNA/RNA Preservation Buffer (100/pk)Biomeme, Inc.QJR2022-12-02
00810096640116Biomeme Franklin three9 Real-Time PCR ThermocyclerBiomeme, Inc.QJR2022-12-02
00810096640123Biomeme Franklin three9 Real-Time PCR ThermocyclerBiomeme, Inc.QJR2022-12-02
00810096640130Biomeme GoDx App for USBiomeme, Inc.QJR2022-12-02
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00884999049413Alinity mABBOTT MOLECULAR INC.QJR2021-03-10