FDA.reportPublic FDA data

Biomeme GoDx App for US

Primary DI
00810096640130
Brand
Biomeme GoDx App for US
Company
Biomeme, Inc.
Model
2.3.5
Device description
App for controlling Biomeme Frankin three9 thermocycler when used with the Biomeme Real-Time RT-PCR SARS-CoV-2 Test
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
00810096640130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810096640130008100966401308100966401300810096640130

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2679307707support@biomeme.com

Regulatory Flags#

DUNS number
079110357
Device count
1
Premarket exempt
true
Lot or batch
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
00810096640017Biomeme Franklin three9 Real-Time PCR Thermocycler2.910000032022-12-02
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
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
00810096640017Biomeme Franklin three9 Real-Time PCR ThermocyclerBiomeme, 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
00884999050457Alinity mABBOTT MOLECULAR INC.QJR2022-09-08
00884999050464Alinity mABBOTT MOLECULAR INC.QJR2022-09-08
00884999050242Alinity mABBOTT MOLECULAR INC.QJR2022-05-20
00884999050280Alinity mABBOTT MOLECULAR INC.QJR2022-05-19
00884999050211Alinity mABBOTT MOLECULAR INC.QJR2021-08-20
00884999050136Alinity mABBOTT MOLECULAR INC.QJR2021-07-16
00884999050020Alinity mABBOTT MOLECULAR INC.QJR2021-05-17
00884999049390Alinity mABBOTT MOLECULAR INC.QJR2021-03-10
00884999049406Alinity mABBOTT MOLECULAR INC.QJR2021-03-10
00884999049413Alinity mABBOTT MOLECULAR INC.QJR2021-03-10