ImmunoDetector Biotin Blocker

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name: ImmunoDetector Biotin Blocker FDA UDI
Generic Name: Microscopy mounting medium IVD FDA UDI
Device Name: Two-step endogenous biotin blocking system used for immunohistochemistry (IHC) and in-situ hybridization (ISH) procedures to block endogenous biotin in frozen and formalin-fixed paraffin-embedded tissues (pancreas, kidney, liver, etc.) that contain higher levels of biotin and may yield false positive results. FDA UDI
Model / Reference: 1000 ml FDA UDI
Description: Two-step endogenous biotin blocking system used for immunohistochemistry (IHC) and in-situ hybridization (ISH) procedures to block endogenous biotin in frozen and formalin-fixed paraffin-embedded tissues (pancreas, kidney, liver, etc.) that contain higher levels of biotin and may yield false positive results. FDA UDI

Identifiers

Catalog Number: BSB 0102 FDA UDI
Primary DI / UDI-DI: B502BSB01020 FDA UDI
FDA Product Code: PPM FDA UDI
GMDN Term: Microscopy mounting medium IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.4010 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Microscopy mounting medium IVD

ImmunoDetector Biotin Blocker by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Bio Sb, Inc.

Sources (1)

FDA UDI 6de9dc3f-350d-497c-92eb-fc33ae9bd4a6 34 fields · synced May 30, 2026