Pink Hematoxylin Counterstainer

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name: Pink Hematoxylin Counterstainer FDA UDI
Generic Name: Biological stain IVD FDA UDI
Device Name: Pink Hematoxylin Counterstainer provides a nuclear pink counterstain for Immunocytochemical, Immunohistochemical and CISH procedures. FDA UDI
Model / Reference: BSB-0360-100 FDA UDI
Description: Pink Hematoxylin Counterstainer provides a nuclear pink counterstain for Immunocytochemical, Immunohistochemical and CISH procedures. FDA UDI

Identifiers

Catalog Number: BSB-0360-100 FDA UDI
Primary DI / UDI-DI: B502BSB03601000 FDA UDI
FDA Product Code: HYJ FDA UDI
GMDN Term: Biological stain IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.1850 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 100 Milliliter FDA UDI

Category: Biological stain IVD

Pink Hematoxylin Counterstainer 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 a26888cd-4925-445a-aa40-50fd444e1265 37 fields · synced May 30, 2026