ImmunoCAP Tryptase Calibrators

Basic Information

• Brand Name: ImmunoCAP Tryptase Calibrators
• Primary DI: 07333066000909
• Version / Model: 10-9526-01
• Catalog Number: 10-9526-01
• Company Name: Phadia AB
• Labeler DUNS: 354019424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-01
• Public Version: 2
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 70c8c08b-af46-4111-b041-8f52083fbb60

Device Description

Contains one vial of each Tryptase Calibrator (Cal-1, Cal-5, Cal-12.5, Cal-50, Cal-200) to form a complete calibration curve for the ImmunoCAP Tryptase method.

Device Characteristics

• Single Use: Yes
• 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
OYL	Tryptase assay system	Immunology	866.5760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53187	Mast cell protease IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of a mast cell protease (e.g., tryptase, chymase), using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07333066000909	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173704	000

Storage Conditions

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