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LIAISON MeMed BV

FDA UDI

Class II (US FDA UDI)

by Diasorin Inc.

Identity

Trade Name
LIAISON MeMed BV FDA UDI
Generic Name
Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid FDA UDI
Device Name
The DiaSorin LIAISON MeMed BV is a semi-quantitative assay that uses chemiluminescent immunoassay (CLIA) technology to measure three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples. FDA UDI
Model / Reference
318470 FDA UDI
Description
The DiaSorin LIAISON MeMed BV is a semi-quantitative assay that uses chemiluminescent immunoassay (CLIA) technology to measure three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples. FDA UDI

Identifiers

Primary DI / UDI-DI
08056771602969 FDA UDI
510(k) Number
K213936 FDA UDI
FDA Product Code
QPS FDA UDI
GMDN Term
Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3215 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: Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid

LIAISON MeMed BV by Diasorin Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid.

Cleared under the same submission

K213936 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diasorin Inc.

Sources (1)

  • FDA UDI a54ff23f-dcea-48f3-bba4-b75a28be2c52 34 fields · synced May 30, 2026