Factor VIII Antibody Screen

Basic Information

• Brand Name: Factor VIII Antibody Screen
• Primary DI: 10888234500001
• Version / Model: F8S
• Catalog Number: F8S
• Company Name: IMMUCOR GTI DIAGNOSTICS, INC.
• Labeler DUNS: 606034197
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-01
• Public Version: 4
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 20c813c1-7aea-48b9-be73-e720e5f52f08

Device Description

The Factor VIII Antibody Screen is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect reactive with recombinant human factor VIII (FVIII) in human serum and plasma.

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
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	864.7290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56022	Coagulation factor VIII IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor VIII in a clinical specimen, using a chromogenic method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234500001	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082205	000

Storage Conditions

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