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ImmunoCAP IgE/ECP/Tryptase Sample Diluent

FDA UDIEUDAMED

Class II (US FDA UDI)

by Phadia GmbH

Identity

Trade Name
ImmunoCAP IgE/ECP/Tryptase Sample Diluent FDA UDI
Generic Name
Plasma protein IVD, reagent FDA UDI
Device Name
ImmunoCAP IgE/ECP/Tryptase Sample Diluent FDA UDI
Model / Reference
34-2264-51 FDA UDI
Description
ImmunoCAP IgE/ECP/Tryptase Sample Diluent FDA UDI

Identifiers

Catalog Number
34-2264-51 FDA UDI
Primary DI / UDI-DI
07333066011356 FDA UDI
510(k) Number
K133404 FDA UDI
FDA Product Code
DGC FDA UDI
GMDN Term
Plasma protein IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5510 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

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: Plasma protein IVD, reagent

ImmunoCAP IgE/ECP/Tryptase Sample Diluent by Phadia GmbH — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Plasma protein IVD, reagent.

Cleared under the same submission

K133404 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phadia GmbH

Sources (2)

  • FDA UDI a25612c2-fb27-442d-8d3a-502565c358fc 37 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026