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LIAISON MeMed BV Control Set

FDA UDI

Class II (US FDA UDI)

by Diasorin Inc.

Identity

Trade Name
LIAISON MeMed BV Control Set FDA UDI
Generic Name
Multiple cell-mediated host immune response marker IVD, control FDA UDI
Device Name
The DiaSorin LIAISON MeMed BV Control Set is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® MeMed BV assay. FDA UDI
Model / Reference
318471 FDA UDI
Description
The DiaSorin LIAISON MeMed BV Control Set is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® MeMed BV assay. FDA UDI

Identifiers

Primary DI / UDI-DI
08056771602976 FDA UDI
510(k) Number
K213936 FDA UDI
FDA Product Code
QCH FDA UDI
GMDN Term
Multiple cell-mediated host immune response marker IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3920 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, control

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

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 3dde84b2-f9a6-40c1-9773-121bf01523bb 34 fields · synced May 30, 2026