Biomeme SARS-CoV-2 Go-Strips Kit

Basic Information

• Brand Name: Biomeme SARS-CoV-2 Go-Strips Kit
• Primary DI: 00810096640048
• Version / Model: 1
• Catalog Number: 3000555
• Company Name: Biomeme, Inc.
• Labeler DUNS: 079110357
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 96
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: 7ab08c59-3ceb-4c59-a684-d7b8fc9db355

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
60091	Nucleic acid amplification mastermix kit IVD	A 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)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10810096640045	GS1
Primary	00810096640048	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]