PolyDetector HRP Black BSB-0361-100

GUDID B502BSB03611000

PolyDetector HRP Black Substrate-Chromogen is suitable for use with peroxidase detection systems and allows for the demonstration of cell antigens or nucleic acids in paraffin-embedded tissues, cryostat sections, cytosmears, and cell preparations.

BIO SB, INC.

Chromogenic/colorimetric substrate reagent IVD

• Primary Device ID: B502BSB03611000
• NIH Device Record Key: d327bf5a-3f1e-45a2-851d-43b27f30c31a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolyDetector HRP Black
• Version Model Number: BSB-0361-100
• Catalog Number: BSB-0361-100
• Company DUNS: 102855447
• Company Name: BIO SB, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com

Device Dimensions

• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B502BSB03611000 [Primary]

FDA Product Code

• NJT: IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-26
• Device Publish Date: 2025-03-18

On-Brand Devices [PolyDetector HRP Black]

• B502BSB03615000: PolyDetector HRP Black Substrate-Chromogen is suitable for use with peroxidase detection systems
• B502BSB0361500: PolyDetector HRP Black Substrate-Chromogen is suitable for use with peroxidase detection systems
• B502BSB03612000: PolyDetector HRP Black Substrate-Chromogen is suitable for use with peroxidase detection systems
• B502BSB0361150: PolyDetector HRP Black Substrate-Chromogen is suitable for use with peroxidase detection systems
• B502BSB036110000: PolyDetector HRP Black Substrate-Chromogen is suitable for use with peroxidase detection systems
• B502BSB03611000: PolyDetector HRP Black Substrate-Chromogen is suitable for use with peroxidase detection systems