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

DYE-INDICATOR, PH (URINARY, NON-QUANT.) (CEN) (6) DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) (JMT) (6) INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) (JIR) (6) METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) (JIL) (6) TEST, URINE LEUKOCYTE (LJX) (5) BLOOD, OCCULT, COLORIMETRIC, IN URINE (JIO) (5) DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) (CDM) (5) NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) (JIN) (5) REFRACTOMETER FOR CLINICAL USE (JRE) (5) AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) (JJB) (4) Single (specified) analyte controls (assayed and unassayed) (JJX) (1) ACID, ASCORBIC, 2,4-DINITROPHENYLHYDRAZINE (SPECTROPHOTOMETRIC) (JMA) (1) ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD (DIC) (1) SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (NBW) (1) CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE (JQP) (1) SYSTEM, HEMOGLOBIN, AUTOMATED (GKR) (1)

Premarket Exempt

No Yes

Clear

Mission Urinalysis Reagent Strips - 00682607000630 Catalog Number :

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

Device Class :

Duns Number: 781100966

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000647 Catalog Number :

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

Device Class :

Duns Number: 781100966

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000654 Catalog Number :

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

Device Class :

Duns Number: 781100966

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000661 Catalog Number :

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

Device Class :

Duns Number: 781100966

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000678 Catalog Number :

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

Device Class :

Duns Number: 781100966

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000685 Catalog Number :

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

Device Class :

Duns Number: 781100966

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 100

On Call Diabetes Management Software - 00682607001118 Catalog Number :

Device Description : PC Software

Device Class : 1

Duns Number: 781100966

Premarket Exempt : No

Product Code : JQP, NBW

Prescription Use : No

Device Count : 1

Mission Capillary Transfer Tubes - 00682607200016 Catalog Number :

Device Description : Box of 50 capillary transfer tubes (25/bag)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 50

Mission Plus Hemoglobin (Hb) Control Solution Kit - 00682607200023 Catalog Number :

Device Description : 2mL bottles of Level 0, Level 1, Level 2

Device Class : 1

Duns Number: 781100966

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Mission Saliva Test Strips - 00682607200054 Catalog Number :

Device Description : Mission Saliva Alcohol Test Strips

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : DIC

Prescription Use : No

Device Count : 25

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