Borrelia All-In-One ViraChip Deca Kit V-BTCFDK

GUDID EVIRBTCFDK1

Immunoassay for the detection of antibodies against Borrelia sp. in human serum.

Viramed Biotech AG

Borrelia burgdorferi total antibody IVD, kit, immunoblot Borrelia burgdorferi total antibody IVD, kit, immunoblot Borrelia burgdorferi total antibody IVD, kit, immunoblot Borrelia burgdorferi total antibody IVD, kit, immunoblot Borrelia burgdorferi total antibody IVD, kit, immunoblot

• Primary Device ID: EVIRBTCFDK1
• NIH Device Record Key: a1487d3d-9826-4b90-b645-82b5c4222eb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Borrelia All-In-One ViraChip Deca Kit
• Version Model Number: V-BTCFDK
• Catalog Number: V-BTCFDK
• 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
• Phone: +4989899336
• Email: xx@xx.xx
• Phone: +4989899336
• Email: xx@xx.xx
• Phone: +4989899336
• Email: xx@xx.xx
• Phone: +4989899336
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EVIRBTCFDK1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220016

FDA Product Code

• LSR: Reagent, Borrelia Serological Reagent

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: 2022-11-16
• Device Publish Date: 2022-11-08

Devices Manufactured by Viramed Biotech AG

• EVIRBPSADK1 - Bordetella pertussis ViraStripe IgA Deca Kit: 2023-07-25 Immunoassay for the detection of IgA antibodies against Bordetella pertussis in human serum.
• EVIRBPSAOK1 - Bordetella pertussis ViraStripe IgA Test Kit: 2023-07-25 Immunoassay for the detection of IgA antibodies against Bordetella pertussis in human serum.
• EVIRBPSGDK1 - Bordetella pertussis ViraStripe IgG Deca Kit: 2023-07-25 Immunoassay for the detection of IgG antibodies against Bordetella pertussis in human serum.
• EVIRBPSGOK1 - Bordetella pertussis ViraStripe IgG Test Kit: 2023-07-25 Immunoassay for the detection of IgG antibodies against Bordetella pertussis in human serum.
• EVIRUVCCAM1 - ViraChip Reader: 2023-07-25 ViraChip Reader
• EVIRUVCSCA1 - ViraChip Scanner: 2023-07-25 ViraChip Scanner
• EVIRBTCFDK1 - Borrelia All-In-One ViraChip Deca Kit: 2022-11-16Immunoassay for the detection of antibodies against Borrelia sp. in human serum.
• EVIRBTCFDK1 - Borrelia All-In-One ViraChip Deca Kit: 2022-11-16 Immunoassay for the detection of antibodies against Borrelia sp. in human serum.
• EVIRBTCFOK1 - Borrelia All-In-One ViraChip Test Kit: 2022-11-16 Immunoassay for the detection of antibodies against Borrelia sp. in human serum.