Smart DetectTM SARS-CoV-2 rRT-PCR Kit

GUDID B379COV2E0

EUA

INBIOS INTERNATIONAL, INC

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• Primary Device ID: B379COV2E0
• NIH Device Record Key: 03a9877d-4b9b-486b-b4ba-74490a3919c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart DetectTM SARS-CoV-2 rRT-PCR Kit
• Version Model Number: COV2-E
• Company DUNS: 004006628
• Company Name: INBIOS INTERNATIONAL, INC
• Device Count: 1
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B379COV2E0 [Primary]

FDA Product Code

• QJR: Reagents, 2019-Novel Coronavirus Nucleic Acid

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: 2020-07-23
• Device Publish Date: 2020-07-15

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