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One+Step Protein

FDA UDI

Class I (US FDA UDI)

by Dfi Co., Ltd

Identity

Trade Name
One+Step Protein FDA UDI
Generic Name
Urine protein IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
100strip/1 bottle FDA UDI
Model / Reference
8194 FDA UDI
Description
100strip/1 bottle FDA UDI

Identifiers

Primary DI / UDI-DI
08806141302025 FDA UDI
FDA Product Code
JIR FDA UDI
GMDN Term
Urine protein IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1645 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Urine protein IVD, kit, rapid colorimetric, clinical

One+Step Protein by Dfi Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine protein IVD, kit, rapid colorimetric, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dfi Co., Ltd

Sources (1)

  • FDA UDI 145d0ae7-6982-41fc-b48a-65c7b5062f5a 34 fields · synced May 30, 2026