Anti-RNP/Sm ELISA

Basic Information

• Brand Name: Anti-RNP/Sm ELISA
• Primary DI: 04048474035780
• Version / Model: EIA-3578
• Catalog Number: EIA-3578
• Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung
• Labeler DUNS: 317134468
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-10
• Public Version: 3
• Public Version Date: 2023-07-26
• Public Version Status: Update
• Public Device Record Key: 0c7380b4-43e6-4e75-bef1-32576c8685f2

Device Description

Anti-RNP/Sm ELISA is a test system for the quantitative measurement of IgG class autoantibodies against RNP/Sm in human serum or plasma.

Device Characteristics

• Single Use: Yes
• 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: Labeling does not contain MRI Safety Information
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LJM	ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS	Immunology	866.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55157	Ribonucleoprotein antibody (anti-RNP) 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 antibodies to ribonucleoprotein (anti-RNP) 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
Primary	04048474035780	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius