HHV-8 [13B10]

GUDID 00847627032836

BIOCARE MEDICAL LLC

Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody Human herpesvirus 8 (HHV8) antigen IVD, antibody

• Primary Device ID: 00847627032836
• NIH Device Record Key: 33a57643-b045-4dc7-b078-71b7a15ffbcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HHV-8 [13B10]
• Version Model Number: APA3290AA
• Company DUNS: 806617825
• Company Name: BIOCARE MEDICAL LLC
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627032836 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

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: 2023-03-01
• Device Publish Date: 2023-02-21

On-Brand Devices [HHV-8 [13B10] ]

• 00847627032867: AVA3290G
• 00847627032850: ALA3290G7
• 00847627032843: OPAA3290T60
• 00847627032836: APA3290AA
• 00847627032829: ACA3290C
• 00847627032812: ACA3290A