Biomeme GoDx App for US

GUDID 00810096640130

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Primary Device ID	00810096640130
NIH Device Record Key	4c4ace22-9e17-4cc6-a9cf-0bd8f000d890
Commercial Distribution Status	In Commercial Distribution
Brand Name	Biomeme GoDx App for US
Version Model Number	2.3.5
Company DUNS	079110357
Company Name	Biomeme, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00810096640130 [Primary]

QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid

Steralize Prior To Use	false
Device Is Sterile	false

00810096640017 - Biomeme Franklin three9 Real-Time PCR Thermocycler	2022-12-12 Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wa
00810096640024 - Biomeme Franklin three9 Real-Time PCR Thermocycler	2022-12-12 Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wa
10810096640038 - Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0	2022-12-12 RNA Extraction Kit containing cartridges, syringes, and binding column tips.
10810096640045 - Biomeme SARS-CoV-2 Go-Strips Kit	2022-12-12 Pre-aliquoted 3-well PCR strips. Each well contains a 20µL lyophilized triplex reaction. Kit includes RNA Process Control (RPC)
10810096640052 - Biomeme SARS-CoV-2 Go-Strips	2022-12-12 Pre-aliquoted 3-well PCR strips. Each well contains a 20µL lyophilized triplex reaction. Assay only.
10810096640069 - Biomeme Void Filling Caps	2022-12-12 Void Filling Caps for sealing Biomeme PCR Go-Strips during thermocycling. Caps only.
10810096640076 - Biomeme RNA Process Control (RPC) Kiit	2022-12-12 RNA Process Control for Biomeme's SARS-CoV-2 assay form factors (Go-Strips, Go-Plate, or Bulk Vials)
10810096640083 - Biomeme SARS-CoV-2 Go-Plates Kit	2022-12-12 Pre-aliquoted 96-well PCR plate. Each well contains a 20µL lyophilized triplex reaction. Kit includes RNA Process Control (RPC)