COVID-19 Coronavirus Real Time PCR Kit

GUDID 06973342000530

Jiangsu Bioperfectus Technologies Co., Ltd.

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• Primary Device ID: 06973342000530
• NIH Device Record Key: 07753f87-f786-4f63-9601-875f437c763e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COVID-19 Coronavirus Real Time PCR Kit
• Version Model Number: 25 Tests
• 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	06973342000530 [Primary]

FDA Product Code

• QQX: Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

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

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• 06973342000240 - Nucleic Acid Extraction Rapid Kit (Magnetic Bead Method): 2023-02-10
• 06973342000257 - Real-time PCR System: 2023-02-10
• 06973342000530 - COVID-19 Coronavirus Real Time PCR Kit: 2023-02-10
• 06973342000530 - COVID-19 Coronavirus Real Time PCR Kit: 2023-02-10
• 06973342000547 - Nucleic Acid Extraction Rapid Kit (Magnetic Bead Method): 2023-02-10
• 06973342000554 - Nucleic Acid Extraction Rapid Kit (Magnetic Bead Method): 2023-02-10