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Human alpha 1 acid glycoprotein Kit for use on SPAPLUS

FDA UDI

Class I (US FDA UDI)

by The Binding Site Group

Identity

Trade Name
Human alpha 1 acid glycoprotein Kit for use on SPAPLUS FDA UDI
Generic Name
Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry FDA UDI
Model / Reference
NK063.S FDA UDI

Identifiers

Primary DI / UDI-DI
05051700016537 FDA UDI
FDA Product Code
LKL FDA UDI
GMDN Term
Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.5420 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Human alpha 1 acid glycoprotein Kit for use on SPAPLUS by The Binding Site Group — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 7556cae8-4410-4be6-9491-3616937cbca7 35 fields · synced May 30, 2026