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

METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) (JIL) (3) INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) (JIR) (2) NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) (JIN) (2) TEST, URINE LEUKOCYTE (LJX) (2) BLOOD, OCCULT, COLORIMETRIC, IN URINE (JIO) (2) DYE-INDICATOR, PH (URINARY, NON-QUANT.) (CEN) (1) DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) (JMT) (1) DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) (CDM) (1) AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) (JJB) (1)

Premarket Exempt

No Yes

Clear

Mission Urinalysis Reagent Strips - 00682607000333 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (BLO)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIO

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000340 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (PH)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : CEN

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000357 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (GLU)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIL

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000364 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (KET)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIN

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000371 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (PRO)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIR

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000388 Catalog Number :

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

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIL, JIR

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000395 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (GLU/KET)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIN, JIL

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000401 Catalog Number :

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

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JMT, LJX

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000418 Catalog Number :

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

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIO, LJX

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000425 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (BIL/URO)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JJB, CDM

Prescription Use : Yes

Device Count : 100

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