Borrelia B31 IgM ViraStripe® Test Kit V-BBSMUS

GUDID EVIRBBSMUS1

Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / B31 im human serum.

Viramed Biotech AG

Borrelia burgdorferi total antibody IVD, kit, immunoblot

• Primary Device ID: EVIRBBSMUS1
• NIH Device Record Key: 71948bfa-ea45-44e6-95e0-718f6a6b3882
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Borrelia B31 IgM ViraStripe® Test Kit
• Version Model Number: V-BBSMUS
• Catalog Number: V-BBSMUS
• 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	EVIRBBSMUS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082329

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: 2016-09-18

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