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Human IgG4 Kit for SPAPLUS (U.S Only)

FDA UDI

Class II (US FDA UDI)

by The Binding Site Group

Identity

Trade Name
Human IgG4 Kit for SPAPLUS (U.S Only) FDA UDI
Generic Name
Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
Model / Reference
LK009.S.A FDA UDI

Identifiers

Primary DI / UDI-DI
05051700017756 FDA UDI
510(k) Number
K072889 FDA UDI
FDA Product Code
CFN FDA UDI
GMDN Term
Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5510 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 IgG4 Kit for SPAPLUS (U.S Only) by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K072889 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 09dd4b48-dd2c-4adf-b294-25dda2193342 36 fields · synced May 29, 2026