ANALYTICAL CONTROL SYSTEMS INC

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

Whole Blood Hemoglobin Determination (KHG) (10)

Premarket Exempt

No Yes

Clear

Hemoglobin G6PDH Normal Control - 00817869020137 Catalog Number : HC-108

Device Class :

Duns Number: 038232682

Premarket Exempt : No

Product Code : KHG

Prescription Use : No

Device Count : 1

Hemoglobin G6PDH Deficient Control - 00817869020144 Catalog Number : HC-108DE

Device Class :

Duns Number: 038232682

Premarket Exempt : No

Product Code : KHG

Prescription Use : No

Device Count : 1

Hemoglobin G6PDH Intermediate Control - 00817869020151 Catalog Number : HC-108IN

Device Class :

Duns Number: 038232682

Premarket Exempt : No

Product Code : KHG

Prescription Use : No

Device Count : 1

Hemoglobin Total Normal Control - 00817869020168 Catalog Number : HC-110

Device Class :

Duns Number: 038232682

Premarket Exempt : No

Product Code : KHG

Prescription Use : No

Device Count : 1

Hemoglobin Total Linearity Control - 00817869020175 Catalog Number : HC-110LIN

Device Class :

Duns Number: 038232682

Premarket Exempt : No

Product Code : KHG

Prescription Use : No

Device Count : 1

Hemoglobin A2 Normal Control - 00817869020182 Catalog Number : HC-111

Device Class :

Duns Number: 038232682

Premarket Exempt : No

Product Code : KHG

Prescription Use : No

Device Count : 1

Hemoglobin A2 Elevated Control - 00817869020199 Catalog Number : HC-111EL

Device Class :

Duns Number: 038232682

Premarket Exempt : No

Product Code : KHG

Prescription Use : No

Device Count : 1

Hemoglobin AE Control - 00817869020205 Catalog Number : HC-117

Device Class :

Duns Number: 038232682

Premarket Exempt : No

Product Code : KHG

Prescription Use : No

Device Count : 1

Hemoglobin FAS Control - 00817869020212 Catalog Number : HC-118

Device Class :

Duns Number: 038232682

Premarket Exempt : No

Product Code : KHG

Prescription Use : No

Device Count : 1

Hemoglobin AD Control - 00817869020229 Catalog Number : HC-120

Device Class :

Duns Number: 038232682

Premarket Exempt : No

Product Code : KHG

Prescription Use : No

Device Count : 1

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