YD Diagnostics CORP.

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

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

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

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

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

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

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

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

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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