Tinto Hepatitis B Virus Core Antigen (Polyclonal)

Basic Information

• Brand Name: Tinto Hepatitis B Virus Core Antigen (Polyclonal)
• Primary DI: B502BSB5611ASR0
• Version / Model: BSB 5611 (ASR)
• Catalog Number: BSB 5611 (ASR)
• Company Name: BIO SB, INC.
• Labeler DUNS: 102855447
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-18
• Public Version: 1
• Public Version Date: 2025-03-26
• Public Version Status: New
• Public Device Record Key: 966cbcbc-5e94-49b5-b1fa-8ab8a3c29c66

Device Description

Tinto Hepatitis B Virus Core Antigen is a purified immunoglobulin fraction of rabbit antiserum that is filtered, sterilized and diluted in buffer pH 7.5, containing BSA and sodium azide as a preservative (analyte specific reagent)

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: 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
MVU	Reagents, specific, analyte	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64705	Assay development analyte-specific reagent IVD	An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B502BSB5611ASR0	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	7	Milliliter

Storage Conditions

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