Primary Device ID | 10810096640090 |
NIH Device Record Key | 16011771-ac52-40d3-a703-8428623fc3d5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Biomeme SARS-CoV-2 Go-Plates |
Version Model Number | 1 |
Catalog Number | 3000634 |
Company DUNS | 079110357 |
Company Name | Biomeme, Inc. |
Device Count | 96 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 2679307707 |
support@biomeme.com | |
Phone | 2679307707 |
support@biomeme.com | |
Phone | 2679307707 |
support@biomeme.com | |
Phone | 2679307707 |
support@biomeme.com | |
Phone | 2679307707 |
support@biomeme.com | |
Phone | 2679307707 |
support@biomeme.com | |
Phone | 2679307707 |
support@biomeme.com | |
Phone | 2679307707 |
support@biomeme.com | |
Phone | 2679307707 |
support@biomeme.com | |
Phone | 2679307707 |
support@biomeme.com | |
Phone | 2679307707 |
support@biomeme.com | |
Phone | 2679307707 |
support@biomeme.com | |
Phone | 2679307707 |
support@biomeme.com | |
Phone | 2679307707 |
support@biomeme.com | |
Phone | 2679307707 |
support@biomeme.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810096640093 [Primary] |
GS1 | 10810096640090 [Unit of Use] |
QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-12 |
Device Publish Date | 2022-12-02 |
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) |