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Cybow 11

FDA UDI

Class I (US FDA UDI)

by Dfi Co., Ltd

Identity

Trade Name
CYBOW 11 FDA UDI
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
QTEST™ 11 FDA UDI
Model / Reference
0A94 FDA UDI
Description
QTEST™ 11 FDA UDI

Identifiers

Primary DI / UDI-DI
08806141300755 FDA UDI
FDA Product Code
CDM FDA UDI
JIR FDA UDI
CEN FDA UDI
JMT FDA UDI
JIN FDA UDI
JIL FDA UDI
JJB FDA UDI
JMA FDA UDI
LJX FDA UDI
JIO 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
862.1645 FDA UDI
862.1550 FDA UDI
862.1510 FDA UDI
862.1435 FDA UDI
862.1340 FDA UDI
862.1115 FDA UDI
862.1095 FDA UDI
864.7675 FDA UDI
864.6550 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

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

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

Cybow 11 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 84f4bdfc-af62-48dd-b2f0-2c0994b6e54a 33 fields · synced May 30, 2026