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Bond

FDA UDI

Class I (US FDA UDI)

by Leica Biosystems Newcastle, Limited

Identity

Trade Name
BOND FDA UDI
Generic Name
Total immunoglobulin G (IgG total) IVD, antibody FDA UDI
Device Name
This reagent is for in vitro diagnostic use. IgG4 (HP6023) is intended to be used for the qualitative identification by light microscopy of human IgG4 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. FDA UDI
Model / Reference
PA0977-U FDA UDI
Description
This reagent is for in vitro diagnostic use. IgG4 (HP6023) is intended to be used for the qualitative identification by light microscopy of human IgG4 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. FDA UDI

Identifiers

Catalog Number
PA0977-U FDA UDI
Primary DI / UDI-DI
05055331336804 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Total immunoglobulin G (IgG 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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Total immunoglobulin G (IgG total) IVD, antibody

Bond by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total immunoglobulin G (IgG total) IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Leica Biosystems Newcastle, Limited

Sources (1)

  • FDA UDI 3ac3e433-7291-40a0-84c4-402165d7c18d 36 fields · synced Jun 1, 2026