YD Diagnostics CORP.

YD Diagnostics CORP.

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

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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

Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (JIL) (6) Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (6) Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (JMT) (4) Blood, Occult, Colorimetric, In Urine (JIO) (4) Dye-Indicator, Ph (Urinary, Non-Quant.) (CEN) (4) Test, Urine Leukocyte (LJX) (4) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (4) Refractometer For Clinical Use (JRE) (3) Enzymatic Method, Creatinine (JFY) (2) Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (JJB) (2) Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (CDM) (2) Reagent, Occult Blood (KHE) (1) Automated Urinalysis System (KQO) (1)

Premarket Exempt

No

Clear

URiSCAN Optima - 08806125619033 Catalog Number :

Device Description : The URiSCAN Optima urine chemistry test system consists of URiSCAN Optima Urine The URiSCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URiSCAN urine test strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN urine test strips and to display and print the results. These measurements are useful in the evaluation of renal, urinary and metabolic disorders.

Device Class : 1

Duns Number: 687769737

Premarket Exempt : No

Product Code : KQO

Prescription Use : No

Device Count : 1

OcculTech Fecal Occult Blood Rapid Test - 08806125630229 Catalog Number :

Device Description : The OcculTech Fecal Occult Blood Rapid Test is a card type rapid test and an imm The OcculTech Fecal Occult Blood Rapid Test is a card type rapid test and an immunochomatography based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices.

Device Class : 2

Duns Number: 687769737

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

URiSCAN 10 SGL strip - 08806125680019 Catalog Number :

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

Device Class : 1

Duns Number: 687769737

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

URiSCAN 2 GP strip - 08806125680033 Catalog Number :

Device Description : Urinalysis dip and read strips for visual.Test for Protein and Glucose in urine.

Device Class : 1

Duns Number: 687769737

Premarket Exempt : No

Product Code : JIL, JIR

Prescription Use : No

Device Count : 1

URiSCAN 6 L strip - 08806125680064 Catalog Number :

Device Description : Urinalysis dip and read strips for visual and URiSCAN urine analyzer.Test for Bl Urinalysis dip and read strips for visual and URiSCAN urine analyzer.Test for Blood, Protein, Nitrite, Glucose, pH and Leucocytes in urine.

Device Class : 1

Duns Number: 687769737

Premarket Exempt : No

Product Code : JIL, LJX, JIO, CEN, JIR, JMT

Prescription Use : No

Device Count : 1

URiSCAN 1 Ketones strip - 08806125680071 Catalog Number :

Device Description : Urinalysis dip and read strips for visual.Test for Ketones in urine.

Device Class : 1

Duns Number: 687769737

Premarket Exempt : No

Product Code : JIN

Prescription Use : No

Device Count : 1

URiSCAN 1 Glucose strip - 08806125680156 Catalog Number :

Device Description : Urinalysis dip and read strips for visual.Test for Glucose in urine.

Device Class : 2

Duns Number: 687769737

Premarket Exempt : No

Product Code : JIL

Prescription Use : No

Device Count : 1

URiSCAN 10 SGL strip - 08806125680217 Catalog Number :

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

Device Class : 1

Duns Number: 687769737

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

URiSCAN 2 ACR strip - 08806125680224 Catalog Number :

Device Description : Urinalysis dip and read strips for URiSCAN urine analyzer.Test for Microalbumin Urinalysis dip and read strips for URiSCAN urine analyzer.Test for Microalbumin and Creatinine in urine.

Device Class : 1

Duns Number: 687769737

Premarket Exempt : No

Product Code : JIR, JFY

Prescription Use : No

Device Count : 1

URiSCAN 10 ACR strip - 08806125680231 Catalog Number :

Device Description : Urinalysis dip and read strips for visual and URiSCAN urine analyzer.Test for Bl Urinalysis dip and read strips for visual and URiSCAN urine analyzer.Test for Blood, Ketones(Acetoacetic Acid), Protein, Nitrite, Glucose, pH, SG(Specific Gravity), Leucocytes, Microalbumin and Creatinine in urine.

Device Class : 1

Duns Number: 687769737

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

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