VARIANT II B-thalassemia

Basic Information

• Brand Name: VARIANT II B-thalassemia
• Primary DI: 00847817009204
• Version / Model: 270-0083
• Catalog Number: 2700083
• Company Name: BIO-RAD LABORATORIES, INC.
• Labeler DUNS: 132528295
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 7
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: a877201a-8e0c-46dd-9ecb-1bb26c68ef6b

Device Description

VARIANT II B-thalassemia Short Program Hemoglobin A2/F Calibrator/Diluent Set

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: Yes
• 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
JPD	HEMOGLOBIN A2 QUANTITATION	Hematology	864.7400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55881	Haemoglobin A2 (HbA2) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype A2 (HbA2) in a clinical specimen.	No	Active
61758	Inherited haemoglobinopathy IVD, calibrator	A material which is used to establish known points of reference for an assay 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.	No	Active
55898	Haemoglobin F (HbF) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype F (HbF), also known as foetal haemoglobin, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847817009204	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K991127	000

Storage Conditions

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