← Back to catalogue

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 1572-1005 FDA UDI

Identifiers

Primary DI / UDI-DI
04049016107026 FDA UDI
510(k) Number
K172244 FDA UDI
FDA Product Code
PIV FDA UDI
KTL 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
866.4750 FDA UDI
866.5100 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
EUROIMMUN Medizinische Labordiagnostika AG

Sources (1)

  • FDA UDI 36cccebe-783d-4a37-aa0a-a3ba2f30d122 33 fields · synced Jun 6, 2026