Spirochete

GUDID 00847627001566

BIOCARE MEDICAL LLC

Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody Treponema pallidum antigen IVD, antibody

• Primary Device ID: 00847627001566
• NIH Device Record Key: 51eb09a2-2a34-4dab-81ae-4ac5949e8127
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spirochete
• Version Model Number: ACI135C
• 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: true
• 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
• 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	00847627001566 [Primary]

FDA Product Code

• MTN: Test, Syphilis, Treponemal
• 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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Spirochete]

• 00847627002075: API135AA
• 00847627001566: ACI135C
• 00847627001559: ACI135B
• 00847627001542: ACI135A