Epstein Barr Virus VCA IgM ELISA EIA-2794

GUDID 00840239027948

The DRG Epstein Barr Virus – Viral Capsid antigen (EBV-VCA) IgM test system is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human serum.

DRG International Inc

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840239027948
• NIH Device Record Key: 4215f6c0-825d-4d3b-9de8-4e3fb3eb9b81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epstein Barr Virus VCA IgM ELISA
• Version Model Number: EIA-2794
• Catalog Number: EIA-2794
• Company DUNS: 075150847
• Company Name: DRG International Inc
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com

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
• 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	00840239027948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944449

FDA Product Code

• LSE: Epstein-Barr Virus, Other

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: 2023-09-01
• Device Publish Date: 2023-08-24

Devices Manufactured by DRG International Inc

• 00840239023858 - Free Triiodothyronine (fT3) ELISA: 2024-10-01 For the quantitative determination of Free Triiodothyronine (fT3) concentration in human serum
• 00840239038012 - Free T3 ELISA: 2024-10-01 The DRG Free T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free triiodothyronine (FT
• 00840239053565 - T3 free: 2024-10-01 The DRG:HYBRiD-XL free T3 is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free Triiodothyronine
• 00840239038470 - Mumps IgM ELISA: 2024-08-28 The Mumps Virus IgM ELISA is intended for the qualitative determination of IgM class antibodies against Mumps Virus in human ser
• 00840239056979 - T-3: 2024-08-21 The DRG:Hybrid-XL T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of T3
• 00840239035769 - Anti-SS-B ELISA: 2023-10-17 Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-B (La) in human serum o
• 00840239048882 - Vitamin C (Ascorbic Acid): 2023-09-11 This colorimetric microtiter plate assay is suitable for the determination of vitamin C (ascorbic acid) in Li-heparin plasma, se
• 00084023903579 - Anti-SS-B ELISA: 2023-09-04 Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-B (La) in human serum o