AIM CRP TEST

Basic Information

• Brand Name: AIM CRP TEST
• Primary DI: 00695684321000
• Version / Model: 32100
• Company Name: GERMAINE LABORATORIES, INC
• Labeler DUNS: 176458115
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-04-27
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7adc35a5-549e-4856-bc15-00a4b5b0c913

Device Description

Latex slide test for C Reactive Protein

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	00695684321000	GS1
Unit of Use	00695684321001	GS1