FDA.reportPublic FDA data

Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0

Primary DI
00810096640031
Brand
Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0
Company
Biomeme, Inc.
Model
1
Catalog number
3000536
Device description
RNA Extraction Kit containing cartridges, syringes, and binding column tips.
Published
2022-12-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00810096640031PrimaryGS10
10810096640038Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810096640031008100966400318100966400310810096640031
1081009664003810810096640038

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid extraction/isolation kit IVDA collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.

Contacts#

Phone, Email table
PhoneEmail
2679307707support@biomeme.com

Regulatory Flags#

DUNS number
079110357
Device count
96
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
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
00810096640130Biomeme GoDx App for USBiomeme, 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