Borrelia B31 ViraChip IgG Deca Kit V-BBCGDK

GUDID EVIRBBCGDK1

Immunoassay for the detection of IgG antibodies against Borrelia burgdorferi s.s. / B31 in human serum.

Viramed Biotech AG

Borrelia burgdorferi total antibody IVD, kit, immunoblot

• Primary Device ID: EVIRBBCGDK1
• NIH Device Record Key: 39304d81-dffc-41cd-bef6-7fc712fdfbd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Borrelia B31 ViraChip IgG Deca Kit
• Version Model Number: V-BBCGDK
• Catalog Number: V-BBCGDK
• Company DUNS: 329748847
• Company Name: Viramed Biotech AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Customer Support Contacts

• Phone: +4989899336
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EVIRBBCGDK1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163504

FDA Product Code

• LSR: Reagent, Borrelia Serological Reagent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-12

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