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Human Beta-2 Microglobulin Kit for use on the SPAPLUS

FDA UDI

Class II (US FDA UDI)

by The Binding Site Group

Identity

Trade Name
Human Beta-2 Microglobulin Kit for use on the SPAPLUS FDA UDI
Generic Name
Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
Model / Reference
LK043.S FDA UDI

Identifiers

Primary DI / UDI-DI
05051700012157 FDA UDI
510(k) Number
K083289 FDA UDI
FDA Product Code
JZG FDA UDI
GMDN Term
Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5630 FDA UDI
Commercial Distribution
Not 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

Human Beta-2 Microglobulin Kit for use on the SPAPLUS by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K083289 also covers:

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 5d03f200-eed2-4f2c-865f-3574e8441d96 36 fields · synced May 30, 2026