YD Diagnostics CORP.

Address:76, Seori-ro, Idong-eup, Cheoin-gu,Yongin-si Gyeonggi,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

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

Premarket Exempt

Clear

UCARE 11 Stick - 08806125680279 Catalog Number :

Device Description : Urinalysis dip and read strips for urine analyzer.Test for Blood, Bilirubin, Uro Urinalysis dip and read strips for urine analyzer.Test for Blood, Bilirubin, Urobilinogen, Ketones(Acetoacetic Acid), Protein, Nitrite, Glucose, pH, SG(Specific Gravity) , Leucocytes and Ascorbic acid in urine.

Device Class : 1

Duns Number: 687769737

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

UCARE 11 Stick - 08806125680286 Catalog Number :

Device Class : 1

Duns Number: 687769737

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

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