RaPET® CRP

Basic Information

• Brand Name: RaPET® CRP
• Primary DI: 00657498001240
• Version / Model: 1130-050
• Catalog Number: 1130-050
• Company Name: STANBIO LABORATORY, L.P.
• Labeler DUNS: 045361136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 05719f41-f384-4340-9bac-0df0b2895813

Device Description

Latex agglutination slide test for the Qualitative and Semi-quantitative determination of C-Reactive Protein in non-diluted serum.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
DCN	System, Test, C-Reactive Protein	Immunology	866.5270	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61988	C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion	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 precipitation/immunodiffusion method. CRP is a marker associated with bacterial infection and inflammatory conditions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00657498001240	GS1

Customer Contacts

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

Storage Conditions

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