PolyDetector Alk Magenta

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name: PolyDetector Alk Magenta FDA UDI
Generic Name: Chromogenic/colorimetric substrate reagent IVD FDA UDI
Device Name: PolyDetector ALK Magenta Substrate-Chromogen used iin Alkaline Phosphatase Detection Systems and allows for the demonstration of cell antigens or nucleic acids in paraffin-embedded tissues, cryostat sections, cytosmears, and cell preparations. FDA UDI
Model / Reference: 100 ml FDA UDI
Description: PolyDetector ALK Magenta Substrate-Chromogen used iin Alkaline Phosphatase Detection Systems and allows for the demonstration of cell antigens or nucleic acids in paraffin-embedded tissues, cryostat sections, cytosmears, and cell preparations. FDA UDI

Identifiers

Catalog Number: BSB 0079 FDA UDI
Primary DI / UDI-DI: B502BSB00790 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 Alk Magenta by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chromogenic/colorimetric substrate reagent IVD.

Trinity Biotech — CLARK LABORATORIES, INC. · Class II
DxSelect™ - Substrate Reagent — DiaSorin Molecular LLC · Class II
IHC — Slmp, LLC · Class I
Bio-Rad — Bio-Rad Laboratories · Class II
Genemed® — Sakura Finetek USA, Inc · Class I
IHC — Slmp, LLC · Class I
IHC — Slmp, LLC · Class I
IHC — Slmp, LLC · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Bio Sb, Inc.

Sources (1)

FDA UDI e7c67528-3fd1-4037-90a6-dd9830ab473b 34 fields · synced May 30, 2026