Biomeme GoDx App for US

Basic Information

• Brand Name: Biomeme GoDx App for US
• Primary DI: 00810096640130
• Version / Model: 2.3.5
• Company Name: Biomeme, Inc.
• Labeler DUNS: 079110357
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: 4c4ace22-9e17-4cc6-a9cf-0bd8f000d890

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Expiration Date: No
• 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
64747	SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810096640130	GS1

Customer Contacts

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