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Human Haptoglobin BINDARID™ Radial Immunodiffusion Kit

FDA UDI

Class II (US FDA UDI)

by The Binding Site Group

Identity

Trade Name
Human Haptoglobin BINDARID™ Radial Immunodiffusion Kit FDA UDI
Generic Name
Haptoglobin IVD, kit, precipitation/immunodiffusion FDA UDI
Model / Reference
RN058.3 FDA UDI

Identifiers

Primary DI / UDI-DI
05051700010740 FDA UDI
510(k) Number
K913670 FDA UDI
FDA Product Code
DAB FDA UDI
GMDN Term
Haptoglobin IVD, kit, precipitation/immunodiffusion FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5460 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: Haptoglobin IVD, kit, precipitation/immunodiffusion

Human Haptoglobin 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 Haptoglobin 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 f484c432-8e5f-40f6-b9db-3958da63e711 35 fields · synced Jun 1, 2026