← Back to catalogue

Just Fitter 10 Parameter Test Strips

FDA UDI

Class I (US FDA UDI)

by Dfi Co., Ltd

Identity

Trade Name
Just Fitter 10 Parameter Test Strips FDA UDI
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
The one device that has DI number included 100 strips FDA UDI
Model / Reference
30C4 FDA UDI
Description
The one device that has DI number included 100 strips FDA UDI

Identifiers

Primary DI / UDI-DI
08806141302209 FDA UDI
510(k) Number
K181024 FDA UDI
FDA Product Code
CDM FDA UDI
CEN FDA UDI
JIL FDA UDI
JIN FDA UDI
JIO FDA UDI
JIR FDA UDI
JJB FDA UDI
JMT FDA UDI
JRE FDA UDI
LJX FDA UDI
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1785 FDA UDI
862.1550 FDA UDI
862.1340 FDA UDI
862.1435 FDA UDI
864.6550 FDA UDI
862.1645 FDA UDI
862.1115 FDA UDI
862.1510 FDA UDI
862.2800 FDA UDI
864.7675 FDA UDI
Commercial Distribution
Not 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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Just Fitter 10 Parameter Test Strips by Dfi Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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
Dfi Co., Ltd

Sources (1)

  • FDA UDI 424756d7-83fa-4419-9a0b-ab73a1bd991b 36 fields · synced Jun 1, 2026