Biotrin Parvovirus B19 IgM EIA

Basic Information

• Brand Name: Biotrin Parvovirus B19 IgM EIA
• Primary DI: 08056771103350
• Version / Model: V619IMUS
• Company Name: DIASORIN SPA
• Labeler DUNS: 630822989
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-27
• Public Version: 1
• Public Version Date: 2019-12-05
• Public Version Status: New
• Public Device Record Key: 65fca112-be9b-4e17-bd68-ab09ce3ab137

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
50164	Parvovirus B19 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Parvovirus B19 in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	EBTRV619IMUS09	HIBCC
Primary	08056771103350	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]