CAROLINA LIQUID CHEMISTRIES CORP.® CRPW RGT. KIT BL-645

Basic Information

• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® CRPW RGT. KIT BL-645
• Primary DI: 00817302022063
• Version / Model: BL645
• Catalog Number: BL645
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Labeler DUNS: 962385787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 4
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 22927194-158e-4eba-ae2a-809679883cdd

Device Description

CRPhsWR (C-Reactive Protein high sensitivity Wide Range) 2 x 100 tests

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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
DCK	C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL	Immunology	866.5270	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53706	C-reactive protein (CRP) IVD, kit, spectrophotometry	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 spectrophotometry 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	00817302022063	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	15	Milliliter
Total Volume	10	Milliliter
Device Size Text, specify			Kit contains 2 R1 and 2 R2 bottles and 1 package insert

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Reagent is stable when stored at 2-8° C until expiration date
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius