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IgE / FITC GPab

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
IgE / FITC GPab FDA UDI
Generic Name
Total immunoglobulin E (IgE total) IVD, antibody FDA UDI
Device Name
The IgE/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris Buffered Saline solution (pH 7.2) FDA UDI
Model / Reference
Concentrate, 1 ml FDA UDI
Description
The IgE/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris Buffered Saline solution (pH 7.2) FDA UDI

Identifiers

Catalog Number
BSB 3011-1 FDA UDI
Primary DI / UDI-DI
B502BSB30111 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Total immunoglobulin E (IgE total) IVD, antibody 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Total immunoglobulin E (IgE total) IVD, antibody

IgE / FITC GPab by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total immunoglobulin E (IgE total) IVD, antibody.

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 9e914a6c-8f95-4f2d-bff5-bc3b9fce7316 34 fields · synced Jun 8, 2026