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MONOBIND, INC.

United States·US-MF-000021611

Last updated September 17, 2026

Information

Country
United States
Address
100, North Pointe Drive, Lake Forest, United States
Website
www.monobind.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1 949 951 2665
PRRC Contact
Tony Shatola
EUDAMED SRN
US-MF-000021611
FDA FEI Number
2020726
DUNS Number
083155515

Catalogue (424)

Page 1 of 9
DeviceModel / ReferenceRegistriesClassStatus
Free T4 AccuBind ELISA Test System - 96 Wells 1225-300
FDA UDI
Class IIActive
Monobind AccuLite Free B-hCG XR CLIA Kit - 192 Wells 10275-300
FDA UDI
Class IIActive
PAPP-A AccuBind ELISA Test System - 192 Wells 12625-300
FDA UDI
N/AActive
Monobind AccuBind IgE ELISA Kit - 192 Wells 2525-300
FDA UDI
Class IIActive
hGH AccuLite CLIA Test System - 192 Wells 1775-300B
FDA UDI
Class IActive
AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 480 Wells 8575-300
FDA UDI
Class IIActive
E2 AccuBind ELISA Test System - 192 Wells 4925-300
FDA UDI
Class IActive
IL-6 AccuLite CLIA Test System - 192 Wells 13275-300
FDA UDI
NActive
Free T4 AccuBind ELISA Test System - 960 Wells 1225-300
FDA UDI
Class IIActive
TSH Rapid AccuLite CLIA Test System - 96 Wells 6075-300
FDA UDI
Class IIActive
T4 AccuBind ELISA Test System - 96 Wells 225-300
FDA UDI
Class IIActive
cTnI AccuBind ELISA Test System - 96 Wells 3825-300
FDA UDI
Class IIActive
SARS-CoV-2 IgM AccuBind ELISA Test System - 192 Wells 11725-300
FDA UDI
NActive
T3 Uptake AccuBind ELISA Test System - 96 Wells 525-300
FDA UDI
Class IIActive
Free T3 AccuBind ELISA Test System - 960 Wells 1325-300
FDA UDI
Class IIActive
Testosterone AccuLite CLIA Test System - 96 Wells 3775-300
FDA UDI
Class IActive
Free B-hCG XR AccuBind ELISA Test System - 96 Wells 2025-300
FDA UDI
Class IIActive
C-Peptide & Insulin Diabetes Panel AccuLite VAST CLIA Test System - 192 Wells 7375-300
FDA UDI
Class IActive
PRL AccuLite CLIA Test System - 192 Wells 775-300
FDA UDI
Class IActive
Cortisol AccuBind ELISA Test System - 96 Wells 3625-300
FDA UDI
Class IIActive
Monobind AccuLite fT3, Ft4, TSH CLIA Kit - 480 Wells 7075-300
FDA UDI
Class IIActive
Monobind Qsure Maternal Control Set MC-300
FDA UDI
Class IActive
D-Dimer AccuBind ELISA Test System - 192 Wells 12025-300
FDA UDI
Class IIActive
hCG Extended Range AccuBind ELISA Test System - 96 Wells 8825-300
FDA UDI
Class IIActive
Free Testosterone AccuBind ELISA Test System - 96 Wells 5325-300
FDA UDI
Class IActive
Vit D Direct AccuBind ELISA Test System - 96 wells 9425-300
FDA UDI
Class IIActive
Monobind AccuLite T3 SBS CLIA Kit - 192 Wells 8175-300
FDA UDI
Class IIActive
Myoglobin AccuLite CLIA Test System - 96 Wells 3275-300
FDA UDI
Class IIActive
T3 AccuBind ELISA Test System - 192 Wells 125-300
FDA UDI
Class IIActive
FSH AccuBind ELISA Test System - 192 Wells 425-300
FDA UDI
Class IActive
Insulin AccuBind ELISA Test System - 192 Wells 2425-300
FDA UDI
Class IActive
Sample Diluent hCG-Free for High-Value Pregnancy Samples 8525145MM
FDA UDI
Class IActive
CEA AccuLite CLIA Test System - 96 Wells 1875-300
FDA UDI
Class IIActive
Calcitonin AccuBind ELISA Test System - 192 Wells 9325-300
FDA UDI
Class IIActive
Monobind AccuBind C-Peptide & Insulin VAST ELISA Kit - 192 Wells 7325-300
FDA UDI
Class IActive
DIG AccuBind ELISA Test System - 96 Wells 925-300
FDA UDI
Class IIActive
Calcitonin AccuBind ELISA Test System - 96 Wells 9325-300
FDA UDI
Class IIActive
uE3 AccuLite CLIA Test System - 96 Wells 5075-300
FDA UDI
Class IActive
Monobind AccuLite Anti-H. Pylori IgM CLIA Kit - 96 Wells 1475-300
FDA UDI
Class IActive
Monobind AccuLite Free T3 CLIA Kit - 480 Wells 1375-300
FDA UDI
Class IIActive
T3 AccuLite CLIA Test System - 960 Wells 175-300
FDA UDI
Class IIActive
Free B-hCG XR AccuBind ELISA Test System - 192 Wells 2025-300
FDA UDI
Class IIActive
17OHP AccuBind ELISA Test System - 96 Wells 5225-300
FDA UDI
Class IActive
Tg AccuLite CLIA Test System - 192 Wells 2275-300
FDA UDI
Class IIActive
T4 AccuLite CLIA Test System - 960 Wells 275-300
FDA UDI
Class IIActive
PRL AccuBind ELISA Test System - 192 Wells 725-300
FDA UDI
Class IActive
Monobind AccuLite LH CLIA Kit - 96 Wells 675-300
FDA UDI
Class IActive
AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 96 Wells 8575-300
FDA UDI
Class IIActive
SHBG AccuBind ELISA Test System - 192 Wells 9125-300
FDA UDI
Class IActive
T3, T4, TSH Thyroid Panel AccuBind VAST AccuBind ELISA Test System - 2592 Wells 8025-300
FDA UDI
Class IIActive

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