DFI CO.,LTD

DFI CO.,LTD

Address:388-25, Gomo-Ro, Jilye-Myeon,,Gimhae-Si Gyeongnam,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (8) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (6) Blood, Occult, Colorimetric, In Urine (JIO) (5) Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (JMT) (5) Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (CDM) (5) Dye-Indicator, Ph (Urinary, Non-Quantitative) (CEN) (5) Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (JIL) (5) Test, Urine Leukocyte (LJX) (5) Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (JJB) (5) Refractometer For Clinical Use (JRE) (3) Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) (JMA) (2) Dye-Indicator, Ph (Urinary, Non-Quant.) (CEN) (1)

Premarket Exempt

No Yes

Clear

CYBOW 11 - 08806141300755 Catalog Number :

Device Description : QTEST™ 11

Device Class :

Duns Number: 688779180

Premarket Exempt : No

Product Code : CDM, JIR, CEN, JMT, JIN, JIL, JJB, JMA, LJX, JIO

Prescription Use : Yes

Device Count : 100

QTEST™ 11 - 08806141301479 Catalog Number :

Device Description : The one device that has DI number included 100 strips.

Device Class : 1

Duns Number: 688779180

Premarket Exempt : No

Product Code : CDM, JIR, CEN, JMT, JIN, JIL, JJB, JMA, LJX, JIO

Prescription Use : Yes

Device Count : 1

QTEST K - 08806141301592 Catalog Number :

Device Description : 100 strips/ 1 bottle

Device Class : 1

Duns Number: 688779180

Premarket Exempt : Yes

Product Code : JIN

Prescription Use : No

Device Count : 1

Yodoc 10 - 08806141301998 Catalog Number :

Device Description : The one device that DI number included 100 strips

Device Class : 1

Duns Number: 688779180

Premarket Exempt : No

Product Code : JIL, JIO, JIR, LJX, JMT, CDM, CEN, JRE, JIN, JJB

Prescription Use : Yes

Device Count : 1

One+Step Protein - 08806141302025 Catalog Number :

Device Description : 100strip/1 bottle

Device Class : 1

Duns Number: 688779180

Premarket Exempt : Yes

Product Code : JIR

Prescription Use : No

Device Count : 1

CYBOW 10 - 08806141302070 Catalog Number :

Device Description : The one device that has DI number included 100 strips

Device Class : 1

Duns Number: 688779180

Premarket Exempt : No

Product Code : JIO, LJX, JJB, JIL, JIN, JMT, CEN, JIR, CDM, JRE

Prescription Use : Yes

Device Count : 1

CYBOW P - 08806141302087 Catalog Number :

Device Description : The one device that has DI number included 50strips

Device Class : 1

Duns Number: 688779180

Premarket Exempt : Yes

Product Code : JIR

Prescription Use : No

Device Count : 1

CYBOW P - 08806141302094 Catalog Number :

Device Description : The one device that has DI number included 100 strips

Device Class : 1

Duns Number: 688779180

Premarket Exempt : Yes

Product Code : JIR

Prescription Use : No

Device Count : 1

Just Fitter 10 Parameter Test Strips - 08806141302209 Catalog Number :

Device Description : The one device that has DI number included 100 strips

Device Class : 1

Duns Number: 688779180

Premarket Exempt : No

Product Code : CDM, CEN, JIL, JIN, JIO, JIR, JJB, JMT, JRE, LJX

Prescription Use : Yes

Device Count : 1

One+Step pH - 08806141302643 Catalog Number :

Device Description : 100strips/ 1 bottle

Device Class : 1

Duns Number: 688779180

Premarket Exempt : Yes

Product Code : CEN

Prescription Use : No

Device Count : 1

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