CYFRA 21-1 EIA

Basic Information

• Brand Name: CYFRA 21-1 EIA
• Primary DI: 17350066140135
• Version / Model: 211-10
• Company Name: Fujirebio Diagnostics AB
• Labeler DUNS: 357159631
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2019-04-09
• Public Version Status: Update
• Public Device Record Key: 0e097631-a8a3-47da-841d-ea5d211b1f9d

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: Yes
• 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
OVK	Cytokeratin Fragments 21-1 Eia Kit	Immunology	866.6010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54612	Cytokeratin IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple cytokeratin subtype(s) in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17350066140135	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100831	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size Type = Tests per kit; Size Unit = 96; Unit of Measure = Tests

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius