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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
T-cell immunoglobulin and mucin domain-containing protein 3 (TIM-3) IVD, antibody FDA UDI
Device Name
TIM-3 (EPR22241) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of TIM-3 protein in formalin-fixed paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). FDA UDI
Model / Reference
PA0360 FDA UDI
Description
TIM-3 (EPR22241) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of TIM-3 protein in formalin-fixed paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). FDA UDI

Identifiers

Catalog Number
PA0360 FDA UDI
Primary DI / UDI-DI
05055331331175 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
T-cell immunoglobulin and mucin domain-containing protein 3 (TIM-3) 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: T-cell immunoglobulin and mucin domain-containing protein 3 (TIM-3) 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 T-cell immunoglobulin and mucin domain-containing protein 3 (TIM-3) 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 01ff1f66-5f6d-4197-8704-4eaa60e5180d 36 fields · synced Jun 6, 2026