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Human Caeruloplasmin NL BINDARID™ Radial Immunodiffusion Kit

FDA UDI

Class II (US FDA UDI)

by The Binding Site Group

Identity

Trade Name
Human Caeruloplasmin NL BINDARID™ Radial Immunodiffusion Kit FDA UDI
Generic Name
Ceruloplasmin IVD, kit, precipitation/immunodiffusion FDA UDI
Model / Reference
RN045.3 FDA UDI

Identifiers

Primary DI / UDI-DI
05051700010719 FDA UDI
510(k) Number
K913668 FDA UDI
FDA Product Code
DDB FDA UDI
GMDN Term
Ceruloplasmin IVD, kit, precipitation/immunodiffusion FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5210 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: Ceruloplasmin IVD, kit, precipitation/immunodiffusion

Human Caeruloplasmin NL BINDARID™ Radial Immunodiffusion Kit by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ceruloplasmin IVD, kit, precipitation/immunodiffusion.

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 613df01a-def4-4de5-8403-22a1529842a4 35 fields · synced May 30, 2026