FDA.reportPublic FDA data

Biomeme SARS-CoV-2 Go-Strips Kit

Primary DI
10810096640045
Brand
Biomeme SARS-CoV-2 Go-Strips Kit
Company
Biomeme, Inc.
Model
1
Catalog number
3000555
Device description
Pre-aliquoted 3-well PCR strips. Each well contains a 20µL lyophilized triplex reaction. Kit includes RNA Process Control (RPC) Kit and Void Filling Caps.
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00810096640048PrimaryGS10
10810096640045Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810096640048008100966400488100966400480810096640048
1081009664004510810096640045

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid amplification mastermix kit IVDA collection of reagents and other associated materials intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)} in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2679307707support@biomeme.com

Regulatory Flags#

DUNS number
079110357
Device count
96
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810096640130Biomeme GoDx App for US2.3.52022-12-02
10810096640038Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0130005362022-12-02
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
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