PolyDetector HRP Yellow BSB-0365-100

GUDID B502BSB03651000

PolyDetector HRP Yellow 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: B502BSB03651000
• NIH Device Record Key: 8548b2dd-7500-48dd-82d6-a31c6edc135c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolyDetector HRP Yellow
• Version Model Number: BSB-0365-100
• Catalog Number: BSB-0365-100
• 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	B502BSB03651000 [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 Yellow]

• B502BSB03655000: PolyDetector HRP Yellow Substrate-Chromogen is suitable for use with peroxidase detection system
• B502BSB0365500: PolyDetector HRP Yellow Substrate-Chromogen is suitable for use with peroxidase detection system
• B502BSB03652000: PolyDetector HRP Yellow Substrate-Chromogen is suitable for use with peroxidase detection system
• B502BSB0365150: PolyDetector HRP Yellow Substrate-Chromogen is suitable for use with peroxidase detection system
• B502BSB036510000: PolyDetector HRP Yellow Substrate-Chromogen is suitable for use with peroxidase detection system
• B502BSB03651000: PolyDetector HRP Yellow Substrate-Chromogen is suitable for use with peroxidase detection system