FETALSCREEN™II

Basic Information

• Brand Name: FETALSCREEN™II
• Primary DI: 10758750006144
• Version / Model: Z488
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-29
• Public Version: 5
• Public Version Date: 2023-06-14
• Public Version Status: Update
• Public Device Record Key: 906f7e41-dc9d-480b-a37f-3a2a8226c3ca

Device Description

FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
MTI	Kit, Cell Screening, Fetal	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
55977	Foeto-maternal haemorrhage/Kleihauer test IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of foetal red blood cells in a maternal clinical specimen, also known as a Kleihauer test, as an indicator of foeto-maternal haemorrhage.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750006144	GS1

Customer Contacts

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