Biomeme Franklin three9 Real-Time PCR Thermocycler

Basic Information

• Brand Name: Biomeme Franklin three9 Real-Time PCR Thermocycler
• Primary DI: 00810096640123
• Version / Model: 2.8
• Catalog Number: 1000018
• Company Name: Biomeme, Inc.
• Labeler DUNS: 079110357
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 3
• Public Version Date: 2025-08-19
• Public Version Status: Update
• Public Device Record Key: eadc6fcf-5112-4c84-96e2-5738fe5bd1de
• Distribution End Date: 2023-05-04

Device Description

Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. White color

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
48031	Thermal cycler nucleic acid amplification analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or quantified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810096640123	GS1

Customer Contacts

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