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Freelite® Human Lambda Free Kit for use on the SPAPLUS

FDA UDI

Class II (US FDA UDI)

by The Binding Site Group

Identity

Trade Name
Freelite® Human Lambda Free Kit for use on the SPAPLUS FDA UDI
Generic Name
Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
Model / Reference
LK018.S FDA UDI

Identifiers

Primary DI / UDI-DI
05051700006477 FDA UDI
FDA Product Code
DEH FDA UDI
GMDN Term
Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5550 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: Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

Freelite® Human Lambda Free Kit for use on the SPAPLUS by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
The Binding Site Group

Sources (1)

  • FDA UDI 74ad3afe-5491-40b2-8b71-371eea8192d4 34 fields · synced May 30, 2026