Mono Mo A-Hu Neutrophil Elastase Cl NP57

FDA UDI

Class I (US FDA UDI)

by Agilent Technologies Singapore Pte Ltd

Identity

Trade Name: Mono Mo A-Hu Neutrophil Elastase Cl NP57 FDA UDI
Generic Name: Neutrophil elastase IVD, antibody FDA UDI
Device Name: Monoclonal Mouse Anti-Human Neutrophil Elastase Clone NP57 FDA UDI
Model / Reference: M0752 FDA UDI
Description: Monoclonal Mouse Anti-Human Neutrophil Elastase Clone NP57 FDA UDI

Identifiers

Primary DI / UDI-DI: 05700572005223 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Neutrophil elastase 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

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

Dimensions & Sizes

Size: Total Volume — 1 Milliliter FDA UDI

Category: Neutrophil elastase IVD, antibody

Mono Mo A-Hu Neutrophil Elastase Cl NP57 by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Tinto Neutrophil Elastase, RMab — BIO SB, INC. · Class I
Rabbit Monoclonal Anti-Human Neutrophil Elastase Antibody, EP223 — EPITOMICS, INC. · Class I
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Neutrophil Elastase RMab — BIO SB, INC. · Class I
Tinto Neutrophil Elastase, RMab — BIO SB, INC. · 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

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Manufacturer

Manufacturer: Agilent Technologies Singapore Pte Ltd

Sources (1)

FDA UDI 84d74329-6773-424b-bf00-0dc13a7e0a41 36 fields · synced May 31, 2026