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ImmunoCAP Tryptase Curve Control 1

FDA UDI

Class II (US FDA UDI)

by Phadia GmbH

Identity

Trade Name
ImmunoCAP Tryptase Curve Control 1 FDA UDI
Generic Name
Mast cell protease IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
ImmunoCAP Tryptase Curve Control 1 FDA UDI
Model / Reference
34-2311-12 FDA UDI
Description
ImmunoCAP Tryptase Curve Control 1 FDA UDI

Identifiers

Catalog Number
34-2311-12 FDA UDI
Primary DI / UDI-DI
07333066011998 FDA UDI
510(k) Number
DEN120001 FDA UDI
FDA Product Code
OYL FDA UDI
GMDN Term
Mast cell protease IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5760 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

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, kit, enzyme immunoassay (EIA)

ImmunoCAP Tryptase Curve Control 1 by Phadia GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mast cell protease IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

DEN120001 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phadia GmbH

Sources (1)

  • FDA UDI 17df81a9-2e7e-4cb1-9580-3cec8361e217 37 fields · synced May 30, 2026