Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit REF:207.01.25.02

GUDID 16973774250012

Biohit Healthcare (Hefei) Co., Ltd.

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

• Primary Device ID: 16973774250012
• NIH Device Record Key: 61d7f668-2b95-48be-a3b7-23f5ecf74f10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit
• Version Model Number: 25 Tests/Kit
• Catalog Number: REF:207.01.25.02
• Company DUNS: 560014279
• Company Name: Biohit Healthcare (Hefei) Co., Ltd.
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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
GS1	06973774250015 [Primary]
GS1	16973774250012 [Package]; Contains: 06973774250015; Package: box [25 Units]; In Commercial Distribution
GS1	26973774250019 [Package]; Package: carton [18 Units]; In Commercial Distribution

FDA Product Code

• QKO: Reagent, Coronavirus Serological

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: 2022-08-24
• Device Publish Date: 2022-08-16

On-Brand Devices [Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit]

• 16973774250012: 25 Tests/Kit
• 06973774259803: 25 Tests/Kit