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IFA: Crithidia luciliae (anti-dsDNA) EUROPattern

FDA UDI

Class II (US FDA UDI)

by EUROIMMUN Medizinische Labordiagnostika AG

Identity

Trade Name
IFA: Crithidia luciliae (anti-dsDNA) EUROPattern FDA UDI
Generic Name
Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
FC 1572-2005 FDA UDI

Identifiers

Primary DI / UDI-DI
04049016107057 FDA UDI
510(k) Number
K172244 FDA UDI
FDA Product Code
KTL FDA UDI
PIV FDA UDI
GMDN Term
Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5100 FDA UDI
866.4750 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay

IFA: Crithidia luciliae (anti-dsDNA) EUROPattern by EUROIMMUN Medizinische Labordiagnostika AG — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay.

Cleared under the same submission

K172244 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
EUROIMMUN Medizinische Labordiagnostika AG

Sources (1)

  • FDA UDI 7427a728-1bde-44c9-921e-eef8574c022d 34 fields · synced May 30, 2026