Bordetella pertussis ViraStripe IgG Test Kit V-BPSGOK

GUDID EVIRBPSGOK1

Immunoassay for the detection of IgG antibodies against Bordetella pertussis in human serum.

Viramed Biotech AG

Bordetella pertussis total antibody IVD, kit, immunoblot

• Primary Device ID: EVIRBPSGOK1
• NIH Device Record Key: c1fa30e6-89ab-401d-b1b9-aa6729d0dc1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bordetella pertussis ViraStripe IgG Test Kit
• Version Model Number: V-BPSGOK
• Catalog Number: V-BPSGOK
• Company DUNS: 329748847
• Company Name: Viramed Biotech AG
• 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: 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
HIBCC	EVIRBPSGOK1 [Primary]

FDA Product Code

• GOX: Antigen, B. Pertussis

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: 2023-07-25
• Device Publish Date: 2023-07-17

Devices Manufactured by Viramed Biotech AG

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• 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: 2023-07-25Immunoassay 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: 2022-11-16 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.