Bond™

FDA UDI

Class I (US FDA UDI)

by Leica Biosystems Newcastle, Limited

Identity

Trade Name: BOND™ FDA UDI
Generic Name: Inhibin A IVD, antibody FDA UDI
Device Name: Inhibin Alpha (R1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human inhibin alpha protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems). FDA UDI
Model / Reference: PA0488-U FDA UDI
Description: Inhibin Alpha (R1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human inhibin alpha protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems). FDA UDI

Identifiers

Catalog Number: PA0448-U FDA UDI
Primary DI / UDI-DI: 05055331335166 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Inhibin A 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Inhibin A 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 Inhibin A IVD, antibody.

Inhibin, Alpha — BIOCARE MEDICAL, LLC · Class I
Inhibin, alpha (MRQ-63) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Inhibin, alpha (R1) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Inhibin, alpha (R1) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Inhibin, alpha (MRQ-63) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
ANTI-INHIBIN-ALPHA — Biogenex Laboratories, Inc. · Class I
FLEX Mono Mo A-Hu Inhibin a Cl R1 RTU (Link) — Agilent Technologies Inc. · 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: Leica Biosystems Newcastle, Limited

Sources (1)

FDA UDI 2f548a13-db17-46eb-8691-90eec63c209b 36 fields · synced May 31, 2026