Xpert HemosIL FII & FV

Basic Information

• Brand Name: Xpert HemosIL FII & FV
• Primary DI: 07332940000936
• Version / Model: GXHEMOSIL-10
• Catalog Number: GXHEMOSIL-10
• Company Name: CEPHEID
• Labeler DUNS: 956711444
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-29
• Public Version: 4
• Public Version Date: 2022-05-03
• Public Version Status: Update
• Public Device Record Key: 34b3903f-b556-4eeb-873d-3a4283b680bb

Device Description

Xpert HemosIL FII & FV kit; 10 test kit

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
NPQ	Test, Factor V Leiden Mutations, Genomic Dna Pcr	Hematology	864.7280	2
NPR	Test, Factor Ii G20210a Mutations, Genomic Dna Pcr	Hematology	864.7280	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59586	Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited thrombophilia, which may be associated with, but not limited to, the prothrombin 20,210 mutation and/or the Factor V Leiden mutation (activated protein C resistance), using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07332940000936	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082118	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 28 Degrees Celsius