Real-time PCR System

GUDID 06973342000257

Jiangsu Bioperfectus Technologies Co., Ltd.

Thermal cycler nucleic acid amplification instrument IVD, manual

• Primary Device ID: 06973342000257
• NIH Device Record Key: a22a0884-1b2a-4787-aa3a-1a1d27c1749c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Real-time PCR System
• Version Model Number: STC-96A PLUS
• Company DUNS: 548535842
• Company Name: Jiangsu Bioperfectus Technologies Co., Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973342000257 [Primary]

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-10
• Device Publish Date: 2023-02-02

On-Brand Devices [Real-time PCR System]

• 06973342002473: STC-96A
• 06973342000257: STC-96A PLUS