ACON LABORATORIES, INC.

Address:5850 Oberlin Drive, # 340,SAN DIEGO,CA,92121,US

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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

BLOOD, OCCULT, COLORIMETRIC, IN URINE (JIO) (10) INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) (JIR) (9) DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) (JMT) (7) METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) (JIL) (7) TEST, URINE LEUKOCYTE (LJX) (6) DYE-INDICATOR, PH (URINARY, NON-QUANT.) (CEN) (5) DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) (CDM) (3) NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) (JIN) (3) AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) (JJB) (3) REFRACTOMETER FOR CLINICAL USE (JRE) (2)

Premarket Exempt

No Yes

Clear

Mission Urinalysis Reagent Strips - 00682607000531 Catalog Number :

Device Description : Mission Urinalysis Reagent Strip (PRO/GLU/LEU/BLO)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIR, JIO, LJX, JIL

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000548 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (PRO/NIT/BLO/LEU)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIR, LJX, JMT, JIO

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000555 Catalog Number :

Device Description : Mission Urinalysis Reagent Strip (GLU/KET/PRO/PH/BLO)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : CEN, JIN, JIO, JIR, JIL

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000562 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (GLU/PRO/NIT/BLO/LEU)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000579 Catalog Number :

Device Description : Mission Urinalysis Reagent Strip (GLU/SG/PRO/PH/BLO)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIO, JIR, JIL, JRE, CEN

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000586 Catalog Number :

Device Description : Mission Urinalysis Reagent Strip (BIL/URO/LEU/NIT/BLO)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : CDM, JJB, JIO, JMT, LJX

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000593 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (GLU/PRO/PH/BLO/NIT/LEU)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000609 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (BIL/SG/BLO/URO/PRO/NIT)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIR, CDM, JMT, JRE, JJB, JIO

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000616 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (GLU/KET/PRO/PH/BLO/NIT/LEU)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000623 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (GLU/BIL/KET/BLO/PH/PRO/URO/NIT)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 100

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