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One+Step 10A

FDA UDI

Class I (US FDA UDI)

by Dfi Co., Ltd

Identity

Trade Name
One+Step 10A FDA UDI
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
One device is included 100 test strips FDA UDI
Model / Reference
30D4 FDA UDI
Description
One device is included 100 test strips FDA UDI

Identifiers

Primary DI / UDI-DI
08806141303497 FDA UDI
FDA Product Code
LJX FDA UDI
JMT FDA UDI
CDM FDA UDI
JJB FDA UDI
JIN FDA UDI
JIR FDA UDI
JMA FDA UDI
CEN FDA UDI
JRE FDA UDI
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.7675 FDA UDI
862.1510 FDA UDI
862.1785 FDA UDI
862.1115 FDA UDI
862.1435 FDA UDI
862.1645 FDA UDI
862.1095 FDA UDI
862.1550 FDA UDI
862.2800 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

Yes

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: Multiple urine analyte IVD, kit, rapid colorimetric, clinical

One+Step 10A by Dfi Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple urine analyte 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 ee216bc5-512b-4dcc-83bf-7360a40b6deb 34 fields · synced Jun 8, 2026