BÜHLMANN fCAL® turbo Reagent Kit

Basic Information

• Brand Name: BÜHLMANN fCAL® turbo Reagent Kit
• Primary DI: EBUHBKCALRSET0
• Version / Model: B-KCAL-RSET
• Company Name: Bühlmann Laboratories AG
• Labeler DUNS: 481261006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-01
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: b5a0a8a0-52bd-4b22-af2d-be1678c15f01

Device Description

Reagent kit for quantitative PETIA assay for the determination of calprotectin (MRP8/14) in human stool specimens

Device Characteristics

• Single Use: No
• 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
NXO	Calprotectin, Fecal	Immunology	866.5180	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53627	Calprotectin IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of calprotectin protein in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EBUHBKCALRSET0	HIBCC

Customer Contacts

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

Storage Conditions

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