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Analytical Control Systems

US

Last updated September 17, 2026

Information

Country
US
Address
9058 Technology Drive, Fishers, IN, 46038
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
1825740
DUNS Number
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Catalogue (74)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
Hemoglobin Total Linearity Control HC-110LIN
FDA UDI
Class IIActive
Hemoglobin G6PDH Intermediate Control HC-108IN
FDA UDI
Class IIActive
Animal Plasma Control Level II SC-113
FDA UDI
Class IIActive
ACE Calibrator SC-132
FDA UDI
Class IIActive
Whole Blood Control Level III SC-127
FDA UDI
Class IIActive
Hemoglobin AC Control Powder HC-105P
FDA UDI
Class IIActive
Hemoglobin G6PDH Normal Control HC-108
FDA UDI
Class IIActive
ACE Elevated Control SC-131EL
FDA UDI
Class IActive
ACE Normal Control SC-131
FDA UDI
Class IActive
HemoglobinAG Philadelphia Control HC-127
FDA UDI
Class IIActive
Hemotec Whole Blood Control Kit Large SC-125, SC-126, H2O
FDA UDI
Class IIActive
Hemoglobin AD Control HC-120
FDA UDI
Class IIActive
Hemoglobin NAFSC Control HC-102N
FDA UDI
Class IIActive
Whole Blood Control Level I SC-125
FDA UDI
Class IIActive
Hemoglobin Variant Control Kit HC-121
FDA UDI
N/AActive
Hemoglobin Total Normal Control HC-110
FDA UDI
Class IIActive
Hemoglobin F Normal Control HC-106
FDA UDI
Class IIActive
Hemotec Whole Blood Control Kit Large WBC-HT-111
FDA UDI
N/AActive
Hemoglobin A2 Elevated Control HC-111EL
FDA UDI
Class IIActive
Hemoglobin AFSC Control HC-102
FDA UDI
Class IIActive
Hemoglobin G6PDH Deficient Control HC-108DE
FDA UDI
Class IIActive
Slide Platelet Aggregation Test Reagent CR-121-1
FDA UDI
Class IIActive
Hemoglobin AS Control HC-104
FDA UDI
Class IIActive
.02M Calcium Chloride CR-109
FDA UDI
Class IIActive
Hemoglobin AC Control HC-105
FDA UDI
Class IIActive
Whole Blood Control Level II SC-126
FDA UDI
Class IIActive
Hemotec Whole Blood Control Kit Small WBC-HT-101
FDA UDI
N/AActive
Hemoglobin FAS Control HC-118
FDA UDI
Class IIActive
Hemoglobin F Abnormal Control HC-106EL
FDA UDI
Class IIActive
Hemoglobin AF Control HC-103
FDA UDI
Class IIActive
Hemoglobin AE Control HC-117
FDA UDI
Class IIActive
Hemoglobin A2 Normal Control HC-111
FDA UDI
Class IIActive
Acs Human Plasma Coagulation Control Level I K893784
FDA 510(k)
Class IIActive
Acs Liquid Thromboplastin K912102
FDA 510(k)
Class IIActive
Therapeutic Drug Monit Control, Set Ii, Level Ii K911170
FDA 510(k)
Class IActive
Normal Angiotensin Converting Enzyme Control K925906
FDA 510(k)
Class IActive
Acs Therapeutic Drug Monit Contr, Set Ii Level Iii K911171
FDA 510(k)
Class IActive
Acs Therapeutic Drug Monit Contols, Level I, Ii, Iii K913677
FDA 510(k)
Class IActive
Acs Ultra-1 Thromboplastin K913249
FDA 510(k)
Class IIActive
Acs Cholesterol/Triglyceride Liquid Control K904829
FDA 510(k)
Class IActive
Sertrol Product # Acs St 101 K800559
FDA 510(k)
Class IActive
Acs Animal Plasma Coagulation Control Level Ii K893971
FDA 510(k)
Class IIActive
Ly-Pro-Trol #acs-Lp101 K791825
FDA 510(k)
Class IActive
Acs Apct Reagent K921118
FDA 510(k)
Class IIActive
Acs Cholestrerol/Triglyceride Liquid Linear Calibr K904767
FDA 510(k)
Class IIActive
Acs Freeze-Dried Aptt Reagent K921223
FDA 510(k)
Class IIActive
Acs Animal Plasma Coagulation Control Level I K893783
FDA 510(k)
Class IIActive
Acs One-Stage Prothrombin Time Reagent K902468
FDA 510(k)
Class IIActive
Acs Therapeutic Drug Monitoring Control, Level Ii K911177
FDA 510(k)
Class IActive
Acs Colloid Osmotic Pressure Calibrator K892213
FDA 510(k)
Class IIActive

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