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

Dye-Indicator, Ph (Urinary, Non-Quantitative) (CEN) (2) Acid, Uric, Uricase (Colorimetric) (KNK) (1) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (1)

Premarket Exempt

No Yes

Clear

One+Step Ketone - 08806141302650 Catalog Number :

Device Description : 100strip / 1 bottle

Device Class : 1

Duns Number: 688779180

Premarket Exempt : Yes

Product Code : JIN

Prescription Use : No

Device Count : 1

QUCARE®Self Total Cholesterol - 08806141302674 Catalog Number :

Device Class :

Duns Number: 688779180

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Just Fitter pH Test Strips - 08806141302766 Catalog Number :

Device Class : 1

Duns Number: 688779180

Premarket Exempt : Yes

Product Code : CEN

Prescription Use : No

Device Count : 1

QUCARE®Self Total Cholesterol - 08806141302896 Catalog Number :

Device Description : The device is included 2 pouch

Device Class :

Duns Number: 688779180

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

One+Step Salive & Urine pH - 08806141303060 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

One+Step Uric Acid - 08806141303077 Catalog Number :

Device Class : 1

Duns Number: 688779180

Premarket Exempt : Yes

Product Code : KNK

Prescription Use : No

Device Count : 1

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