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.

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Primary Device ID00810096640130
NIH Device Record Key4c4ace22-9e17-4cc6-a9cf-0bd8f000d890
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiomeme GoDx App for US
Version Model Number2.3.5
Company DUNS079110357
Company NameBiomeme, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2679307707
Emailsupport@biomeme.com
Phone2679307707
Emailsupport@biomeme.com
Phone2679307707
Emailsupport@biomeme.com
Phone2679307707
Emailsupport@biomeme.com
Phone2679307707
Emailsupport@biomeme.com
Phone2679307707
Emailsupport@biomeme.com
Phone2679307707
Emailsupport@biomeme.com
Phone2679307707
Emailsupport@biomeme.com
Phone2679307707
Emailsupport@biomeme.com
Phone2679307707
Emailsupport@biomeme.com
Phone2679307707
Emailsupport@biomeme.com
Phone2679307707
Emailsupport@biomeme.com
Phone2679307707
Emailsupport@biomeme.com
Phone2679307707
Emailsupport@biomeme.com
Phone2679307707
Emailsupport@biomeme.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810096640130 [Primary]

FDA Product Code

QJRReagents, 2019-Novel Coronavirus Nucleic Acid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-12
Device Publish Date2022-12-02

Devices Manufactured by Biomeme, Inc.

00810096640017 - Biomeme Franklin three9 Real-Time PCR Thermocycler2022-12-12 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 Thermocycler2022-12-12 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 2.02022-12-12 RNA Extraction Kit containing cartridges, syringes, and binding column tips.
10810096640045 - Biomeme SARS-CoV-2 Go-Strips Kit2022-12-12 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-Strips2022-12-12 Pre-aliquoted 3-well PCR strips. Each well contains a 20µL lyophilized triplex reaction. Assay only.
10810096640069 - Biomeme Void Filling Caps2022-12-12 Void Filling Caps for sealing Biomeme PCR Go-Strips during thermocycling. Caps only.
10810096640076 - Biomeme RNA Process Control (RPC) Kiit2022-12-12 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 Kit2022-12-12 Pre-aliquoted 96-well PCR plate. Each well contains a 20µL lyophilized triplex reaction. Kit includes RNA Process Control (RPC)

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