ALTA DIAGNOSTICS INC

Address:3123 Research Way Ste 214,Carson City,NV,89706,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

Urinalysis Controls (Assayed And Unassayed) (JJW) (10)

Premarket Exempt

No Yes

Clear

NA - 10858512007003 Catalog Number : 301-1

Device Description : Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at r Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.

Device Class : 1

Duns Number: 859323297

Premarket Exempt : No

Product Code : JJW

Prescription Use : Yes

Device Count : 1

NA - 10858512007010 Catalog Number : 301-2

Device Description : Liquid Urine Control Dipstick - Positive, 20 ml. 8 week open vial stability at r Liquid Urine Control Dipstick - Positive, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.

Device Class : 1

Duns Number: 859323297

Premarket Exempt : No

Product Code : JJW

Prescription Use : Yes

Device Count : 1

NA - 10858512007034 Catalog Number : 303-1

Device Description : Liquid Urine Control Dipstick - Negative, 30 ml. 8 week open vial stability at r Liquid Urine Control Dipstick - Negative, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.

Device Class :

Duns Number: 859323297

Premarket Exempt : No

Product Code : JJW

Prescription Use : Yes

Device Count : 1

NA - 10858512007041 Catalog Number : 303-2

Device Description : Liquid Urine Control Dipstick - Positive, 30 ml. 8 week open vial stability at r Liquid Urine Control Dipstick - Positive, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.

Device Class : 1

Duns Number: 859323297

Premarket Exempt : No

Product Code : JJW

Prescription Use : Yes

Device Count : 1

NA - 10858512007065 Catalog Number : 301-3

Device Description : Liquid Urine Control for Microscopic and High Specific Gravity - Positive, 250 m Liquid Urine Control for Microscopic and High Specific Gravity - Positive, 250 ml. 18 month open vial stability when stored at 2-8° C. Contains Polystyrene and Latex.

Device Class : 1

Duns Number: 859323297

Premarket Exempt : No

Product Code : JJW

Prescription Use : Yes

Device Count : 1

NA - 10858512007072 Catalog Number : 301-4

Device Description : Liquid Urine Control for Microscopic and High Specific Gravity - Negative, 250 m Liquid Urine Control for Microscopic and High Specific Gravity - Negative, 250 ml. 18 month open vial stability when stored at 2-8° C.

Device Class : 1

Duns Number: 859323297

Premarket Exempt : No

Product Code : JJW

Prescription Use : Yes

Device Count : 1

NA - 10858512007089 Catalog Number : 323-16-1

Device Description : Liquid Urine Control - Level 1, 10 ml. 18 month open vial stability when stored at 2-8° C.

Device Class : 1

Duns Number: 859323297

Premarket Exempt : No

Product Code : JJW

Prescription Use : Yes

Device Count : 1

NA - 10858512007096 Catalog Number : 323-16-2

Device Description : Liquid Urine Control - Level 2, 10 ml. 18 month open vial stability when stored at 2-8° C.

Device Class : 1

Duns Number: 859323297

Premarket Exempt : No

Product Code : JJW

Prescription Use : Yes

Device Count : 1

NA - 10858512007119 Catalog Number : 323-17-1

Device Description : Liquid Urine Control - Level 1, 25 ml. 18 month open vial stability when stored at 2-8° C.

Device Class : 1

Duns Number: 859323297

Premarket Exempt : No

Product Code : JJW

Prescription Use : Yes

Device Count : 1

NA - 10858512007126 Catalog Number : 323-17-2

Device Description : Liquid Urine Control - Level 2, 25 ml. 18 month open vial stability when stored at 2-8° C.

Device Class : 1

Duns Number: 859323297

Premarket Exempt : No

Product Code : JJW

Prescription Use : Yes

Device Count : 1

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