VARIANT nbs Newborn Screening

Basic Information

• Brand Name: VARIANT nbs Newborn Screening
• Primary DI: 00847817000560
• Version / Model: 250-3010
• Catalog Number: 2503010
• Company Name: BIO-RAD LABORATORIES, INC.
• Labeler DUNS: 132528295
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-31
• Public Version: 1
• Public Version Date: 2023-02-08
• Public Version Status: New
• Public Device Record Key: ad8cc83e-b577-448b-a15e-fdc58d09c539

Device Description

VARIANT nbs Newborn Screening System

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GKA	ABNORMAL HEMOGLOBIN QUANTITATION	Hematology	864.7415	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61759	Inherited haemoglobinopathy IVD, kit, liquid chromatography	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia, using a liquid chromatography method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847817000560	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius