Mouse/Rabbit ImmunoDetector AEC HRP Red BSB 0008

GUDID B502BSB00080

High sensitivity 2-step detection system designed for detection of specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.

BIO SB, INC.

Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry

• Primary Device ID: B502BSB00080
• NIH Device Record Key: 2b6de61e-c6a1-4838-863b-fa3d4a31d5dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mouse/Rabbit ImmunoDetector AEC HRP Red
• Version Model Number: 200ml each
• Catalog Number: BSB 0008
• Company DUNS: 102855447
• Company Name: BIO SB, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B502BSB00080 [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: 2020-10-08
• Device Publish Date: 2020-09-30

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• B502BSB00080: High sensitivity 2-step detection system designed for detection of specific cellular markers in