← Back to catalogue

LIAISON® XL Zika Capture IgM II

FDA UDI

Class II (US FDA UDI)

by Diasorin Inc.

Identity

Trade Name
LIAISON® XL Zika Capture IgM II FDA UDI
Generic Name
Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Model / Reference
317150 FDA UDI

Identifiers

Primary DI / UDI-DI
08056771602624 FDA UDI
510(k) Number
K192046 FDA UDI
FDA Product Code
QFO FDA UDI
GMDN Term
Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3935 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

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: Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

LIAISON® XL Zika Capture IgM II by Diasorin Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K192046 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
Diasorin Inc.

Sources (1)

  • FDA UDI 27502a43-c99b-413f-8442-fac932691b22 34 fields · synced Jun 8, 2026