Treponema pallidum (Spirochete)

GUDID 00847627001368

BIOCARE MEDICAL LLC

Treponema pallidum antigen IVD, antibody

• Primary Device ID: 00847627001368
• NIH Device Record Key: 348073fc-a4cf-4d73-be1c-9b7e5a65c798
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Treponema pallidum (Spirochete)
• Version Model Number: ACA135B
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627001368 [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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Treponema pallidum (Spirochete)]

• 00847627031730: OPAA135T60
• 00847627027313: ALA135G7
• 00847627001900: APA135AA
• 00847627001351: ACA135A
• 00847627001375: ACA135C
• 00847627001368: ACA135B
• 00847627035363: AVA135G