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Optilite Caeruloplasmin Kit

FDA UDI

Class II (US FDA UDI)

by The Binding Site Group

Identity

Trade Name
Optilite Caeruloplasmin Kit FDA UDI
Generic Name
Ceruloplasmin IVD, kit, nephelometry/turbidimetry FDA UDI
Model / Reference
NK045.OPT.A FDA UDI

Identifiers

Primary DI / UDI-DI
05051700018197 FDA UDI
FDA Product Code
DDB FDA UDI
GMDN Term
Ceruloplasmin IVD, kit, nephelometry/turbidimetry 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, nephelometry/turbidimetry

Optilite Caeruloplasmin 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, 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 6fcfc254-cb28-4e6f-8c89-2e89798e4baf 34 fields · synced Jun 6, 2026