IDG/Sanzay

FDA UDI

Class II (US FDA UDI)

by IDG/SANZAY Corporation

Identity

Trade Name: IDG/Sanzay FDA UDI
Generic Name: Total protein IVD, reagent FDA UDI
Device Name: For the quantitative determination of total protein concentration in human serum. FDA UDI
Model / Reference: 1 FDA UDI
Description: For the quantitative determination of total protein concentration in human serum. FDA UDI

Identifiers

Catalog Number: C391 FDA UDI
Primary DI / UDI-DI: 00850053916144 FDA UDI
510(k) Number: K864743 FDA UDI
FDA Product Code: CEK FDA UDI
GMDN Term: Total protein IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1635 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 100 Milliliter FDA UDI
Total Volume — 120 Milliliter FDA UDI
Total Volume — 1 Liter FDA UDI

Category: Total protein IVD, reagent

IDG/Sanzay by IDG/SANZAY Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Alinity — ABBOTT IRELAND · Class II

Cleared under the same submission

K864743 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: IDG/SANZAY Corporation

Sources (1)

FDA UDI 01aeb147-0e14-4327-bc41-48459849b2ad 37 fields · synced May 30, 2026