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FLEX Mono Mo A-Hu Mast Cell Tryptase Cl AA1 RTU (Link)

FDA UDI

Class I (US FDA UDI)

by Agilent Technologies Singapore Pte Ltd

Identity

Trade Name
FLEX Mono Mo A-Hu Mast Cell Tryptase Cl AA1 RTU (Link) FDA UDI
Generic Name
Mast cell protease IVD, antibody FDA UDI
Device Name
FLEX Monoclonal Mouse Anti-Human Mast Cell Tryptase Clone AA1 Ready-to-Use (Link) FDA UDI
Model / Reference
IR640 FDA UDI
Description
FLEX Monoclonal Mouse Anti-Human Mast Cell Tryptase Clone AA1 Ready-to-Use (Link) FDA UDI

Identifiers

Primary DI / UDI-DI
05700572030225 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Mast cell protease 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Mast cell protease IVD, antibody

FLEX Mono Mo A-Hu Mast Cell Tryptase Cl AA1 RTU (Link) by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Mast cell protease IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Agilent Technologies Singapore Pte Ltd

Sources (1)

  • FDA UDI 3b63cca7-ba27-4557-aba7-e5d04eaf213a 36 fields · synced May 30, 2026