Mouse/Rabbit ImmunoDetector AP, w/ALK Scarlet Detection System

Basic Information

• Brand Name: Mouse/Rabbit ImmunoDetector AP, w/ALK Scarlet Detection System
• Primary DI: B502BSB03502000
• Version / Model: 200 ml each (2000 tests)
• Catalog Number: BSB 0350-200
• Company Name: BIO SB, INC.
• Labeler DUNS: 102855447
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-30
• Public Version: 1
• Public Version Date: 2020-10-08
• Public Version Status: New
• Public Device Record Key: 0457c5e0-2ad6-4963-a18f-4469a4d0a2c2

Device Description

The Mouse/Rabbit ImmunoDetector Alkaline Phosphatase/ ALK Scarlet Detection System is a Biotin-Streptavidin-Alkaline Phosphatase Detection System used for the demonstration of antigens in formalin-fixed paraffin-embedded tissue, cryostat sections, cytosmears, and cell preparations

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
NJT	Immunohistochemistry Reagents And Kits	Hematology	864.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57767	Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B502BSB03502000	HIBCC