ihcDirect® Cytokeratin 19 Ab

Basic Information

• Brand Name: ihcDirect® Cytokeratin 19 Ab
• Primary DI: 00850000596443
• Version / Model: K32033-005
• Catalog Number: K32033-005
• Company Name: NOVODIAX, INC.
• Labeler DUNS: 965326957
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-22
• Public Version: 2
• Public Version Date: 2021-08-10
• Public Version Status: Update
• Public Device Record Key: bb64df8a-669a-418d-8fdb-ff982982c4c8
• Distribution End Date: 2021-08-10

Device Description

Clone R1002

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
NJT	Immunohistochemistry Reagents And Kits	Hematology	864.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57073	Cytokeratin IVD, kit, enzyme immunohistochemistry	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 an enzyme immunohistochemistry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850000596443	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	5	Milliliter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 21 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius