CMV Brite™[Only 5 CMV control slides], CMV Antigenemia Test Kit VIR-BDC100 CHS

GUDID 08717953022325

The CMV Brite™ Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence in isolated peripheral blood leukocytes obtained from EDTA and heparin anticoagulated human peripheral blood. The detection of CMV pp65 in human leukocytes aids in the diagnosis of acute or reactivated CMV infection.

IQ Products B.V.

Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay

• Primary Device ID: 08717953022325
• NIH Device Record Key: 8a0fd8b3-4b6a-432a-a7e4-4d3c25c5af46
• Commercial Distribution Discontinuation: 2021-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CMV Brite™[Only 5 CMV control slides], CMV Antigenemia Test Kit
• Version Model Number: VIR-BDC100 CHS
• Catalog Number: VIR-BDC100 CHS
• Company DUNS: 490578678
• Company Name: IQ Products B.V.
• 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: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl
• Phone: +31505757000
• Email: techsupport@iqproducts.nl

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
GS1	08717953022325 [Primary]

FDA Product Code

• LIN: Antisera, Conjugated Fluorescent, Cytomegalovirus

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-09-14
• Device Publish Date: 2016-09-19

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• 08717953022325 - CMV Brite™[Only 5 CMV control slides], CMV Antigenemia Test Kit: 2022-09-14The CMV Brite™ Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence in isolated peripheral blood leukocytes obtained from EDTA and heparin anticoagulated human peripheral blood. The detection of CMV pp65 in human leukocytes aids in the diagnosis of acute or reactivated CMV infection.
• 08717953022325 - CMV Brite™[Only 5 CMV control slides], CMV Antigenemia Test Kit: 2022-09-14 The CMV Brite™ Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect im
• 08717953022349 - CMV Brite™, CMV antigenemia detection kit: 2022-09-14 The CMV Brite™ Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect im