ANALYTICAL CONTROL SYSTEMS INC

Address:9058 Technology Drive,Fishers,IN,46038,US

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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

Premarket Exempt

No Yes

Clear

Hemotec Whole Blood Control Kit Small - 00817869020342 Catalog Number :

Device Description : Whole Blood Control Kit containing 2 vials of each: SC-125, SC-126, and DW-10

Device Class :

Duns Number: 038232682

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Hemoglobin Variant Control Kit - 00817869020359 Catalog Number : HC-121

Device Class :

Duns Number: 038232682

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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