PolyDetector HRP Green kit

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name: PolyDetector HRP Green kit FDA UDI
Generic Name: Chromogenic/colorimetric substrate reagent IVD FDA UDI
Device Name: PolyDetector HRP Green Substrate-Chromogen Kit is suitable for use with peroxidase detection systems, which allow the demonstration of cell antigens or nucleic acids in paraffin-embedded tissues, cryostat sections, cytosmears, and cell preparation FDA UDI
Model / Reference: 10000 Tests FDA UDI
Description: PolyDetector HRP Green Substrate-Chromogen Kit is suitable for use with peroxidase detection systems, which allow the demonstration of cell antigens or nucleic acids in paraffin-embedded tissues, cryostat sections, cytosmears, and cell preparation FDA UDI

Identifiers

Catalog Number: BSB 0133 FDA UDI
Primary DI / UDI-DI: B502BSB01330 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Chromogenic/colorimetric substrate reagent IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.1860 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

Yes

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: Chromogenic/colorimetric substrate reagent IVD

PolyDetector HRP Green kit 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 8230a76a-f508-4fc1-82d4-78420334962f 34 fields · synced May 31, 2026