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Mouse/Rabbit ImmunoDetector AP, w/ALK Scarlet Detection System

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
Mouse/Rabbit ImmunoDetector AP, w/ALK Scarlet Detection System FDA UDI
Generic Name
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDI
Device Name
The Mouse/Rabbit ImmunoDetector Alkaline Phosphatase/ ALK Scarlet Detection System is a Biotin-Streptavidin-Alkaline Phosphatase Detection System used for the demonstration of antigens in formalin-fixed paraffin-embedded tissue, cryostat sections, cytosmears, and cell preparations FDA UDI
Model / Reference
1000 ml each (10000 tests) FDA UDI
Description
The Mouse/Rabbit ImmunoDetector Alkaline Phosphatase/ ALK Scarlet Detection System is a Biotin-Streptavidin-Alkaline Phosphatase Detection System used for the demonstration of antigens in formalin-fixed paraffin-embedded tissue, cryostat sections, cytosmears, and cell preparations FDA UDI

Identifiers

Catalog Number
BSB 0350-1000 FDA UDI
Primary DI / UDI-DI
B502BSB035010000 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Mouse/Rabbit ImmunoDetector AP, w/ALK Scarlet Detection System by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio Sb, Inc.

Sources (1)

  • FDA UDI 44ba3434-9cf0-4120-b283-d195b23e1a91 34 fields · synced May 30, 2026