C-Reactive Protein HS ELISA

Basic Information

• Brand Name: C-Reactive Protein HS ELISA
• Primary DI: 00840239039545
• Version / Model: EIA-3954
• Catalog Number: EIA-3954
• Company Name: DRG International Inc
• Labeler DUNS: 075150847
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-20
• Public Version: 4
• Public Version Date: 2023-08-16
• Public Version Status: Update
• Public Device Record Key: 59ad9cbe-8b05-4bd9-817d-d80870eaa11d

Device Description

The C-Reactive Protein HS ELISA is intended for the quantitative determination of C-reactive protein (CRP) in human serum. Enhanced sensitivity measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DCK	C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL	Immunology	866.5270	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58768	C-reactive protein (CRP) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen, using a fluorescent immunoassay method [includes high-sensitivity CRP (hsCRP) types]. CRP is a marker associated with bacterial infection, inflammatory conditions, and cardiovascular disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840239039545	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Stop Solution
Device Size Text, specify			TMB
Total Volume	50	Milliliter
Device Size Text, specify			Sample Diluent
Total Volume	12	Milliliter
Total Volume	1	Milliliter
Device Size Text, specify			Standards
Total Volume	11	Milliliter
Device Size Text, specify			Conjugate Reagent