Biomeme GoDx App for US

GUDID 00810096640130

App for controlling Biomeme Frankin three9 thermocycler when used with the Biomeme Real-Time RT-PCR SARS-CoV-2 Test

Biomeme, Inc.

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

Customer Support Contacts

• Phone: 2679307707
• Email: support@biomeme.com
• Phone: 2679307707
• Email: support@biomeme.com
• Phone: 2679307707
• Email: support@biomeme.com
• Phone: 2679307707
• Email: support@biomeme.com
• Phone: 2679307707
• Email: support@biomeme.com
• Phone: 2679307707
• Email: support@biomeme.com
• Phone: 2679307707
• Email: support@biomeme.com
• Phone: 2679307707
• Email: support@biomeme.com
• Phone: 2679307707
• Email: support@biomeme.com
• Phone: 2679307707
• Email: support@biomeme.com
• Phone: 2679307707
• Email: support@biomeme.com
• Phone: 2679307707
• Email: support@biomeme.com
• Phone: 2679307707
• Email: support@biomeme.com
• Phone: 2679307707
• Email: support@biomeme.com
• Phone: 2679307707
• Email: support@biomeme.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810096640130 [Primary]

FDA Product Code

• QJR: Reagents, 2019-Novel Coronavirus Nucleic Acid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-12
• Device Publish Date: 2022-12-02

Devices Manufactured by Biomeme, Inc.

• 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)