← Back to catalogue

Human IgG1 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and Hitach

FDA UDI

Class II (US FDA UDI)

by The Binding Site Group

Identity

Trade Name
Human IgG1 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and Hitach FDA UDI
Generic Name
Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
Model / Reference
NK006.H FDA UDI

Identifiers

Primary DI / UDI-DI
05051700007597 FDA UDI
FDA Product Code
DFZ 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
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: Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Human IgG1 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and Hitach by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
The Binding Site Group

Sources (1)

  • FDA UDI daad158b-350f-4f6e-8db6-219606b654fe 34 fields · synced May 30, 2026