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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 6 of 9
DeviceModel / ReferenceRegistriesClassStatus
PCT AccuLite CLIA Test System - 192 Wells 9275-300
FDA UDI
Class IIActive
T3 SBS AccuBind ELISA Test System - 192 Wells 8125-300
FDA UDI
Class IIActive
Monobind AccuLite T4 CLIA Kit - 192 Wells 275-300
FDA UDI
Class IIActive
Cortisol AccuBind ELISA Test System - 192 Wells 3625-300
FDA UDI
Class IIActive
T3, T4, TSH Thyroid Panel AccuBind VAST AccuBind ELISA Test System - 960 Wells 8025-300
FDA UDI
Class IIActive
Folate AccuBind ELISA Test System - 96 Wells 7525-300
FDA UDI
Class IIActive
Insulin AccuLite CLIA Test System - 192 Wells 2475-300
FDA UDI
Class IActive
AMH AccuBind ELISA Test System - 192 Wells 9725-300
FDA UDI
Class IIActive
AMH AccuBind ELISA Test System - 96 Wells 9725-300
FDA UDI
Class IIActive
Monobind AccuBind Insulin Rapid ELISA Kit - 96 Wells 5825-300
FDA UDI
Class IActive
PTH Whole & Intact AccuBind VAST ELISA Test System - 192 Wells 10025-300
FDA UDI
Class IIActive
Titin-s ELISA Analyzer IN016-E
FDA UDI
Class IActive
D-Dimer AccuLite CLIA Test System - 192 Wells 12075-300
FDA UDI
Class IIActive
PAPP-A AccuLite CLIA Test System - 192 Wells 12675-300
FDA UDI
N/AActive
Monobind AccuBind DIG ELISA Kit - 192 Wells 925-300
FDA UDI
Class IIActive
T3 SBS AccuBind ELISA Test System - 96 Wells 8125-300
FDA UDI
Class IIActive
AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 480 Wells 8525-300
FDA UDI
Class IIActive
Monobind Qsure Multi-Ligand Control Set ML-300
FDA UDI
Class IActive
sTfR AccuBind ELISA Test System - 96 Wells 8625-300
FDA UDI
Class IIActive
LH AccuLite CLIA Test System - 192 Wells 675-300
FDA UDI
Class IActive
17OHP AccuLite CLIA Test System - 192 Wells 5275-300
FDA UDI
Class IActive
Ferritin AccuBind ELISA Test System - 96 Wells 2825-300
FDA UDI
Class IIActive
T4 SBS AccuLite CLIA Test System - 192 Wells 8275-300
FDA UDI
Class IIActive
Total PSA AccuBind ELISA Test System - 192 Wells 2125-300
FDA UDI
Class IIActive
T4 AccuBind ELISA Test System - 192 Wells 225-300
FDA UDI
Class IIActive
SHBG AccuLite CLIA Test System - 192 Wells 9175-300
FDA UDI
Class IActive
DIG AccuLite CLIA Test System - 192 Wells 975-300
FDA UDI
Class IIActive
TSH Rapid AccuLite CLIA Test System - 192 Wells 6075-300
FDA UDI
Class IIActive
PCT AccuLite CLIA Test System - 96 Wells 9275-300
FDA UDI
Class IIActive
ANST AccuLite CLIA Test System - 192 Wells 12475-300
FDA UDI
Class IActive
T3 AccuBind ELISA Test System - 960 Wells 125-300
FDA UDI
Class IIActive
Free T4 AccuLite CLIA Test System - 480 Wells 1275-300
FDA UDI
Class IIActive
DHEA-S AccuLite CLIA Test System - 192 Wells 5175-300
FDA UDI
Class IActive
hGH AccuBind ELISA Test System - 96 Wells 1725-300A
FDA UDI
Class IActive
LH AccuBind ELISA Test System - 192 Wells 625-300
FDA UDI
Class IActive
Monobind AccuBind TSH Rapid ELISA Kit - 96 Wells 6025-300
FDA UDI
Class IIActive
T4 SBS AccuLite CLIA Test System - 96 Wells 8275-300
FDA UDI
Class IIActive
AFP AccuBind ELISA Test System - 192 Wells 1925-300
FDA UDI
Class IIActive
T3 Uptake AccuBind ELISA Test System - 192 Wells 525-300
FDA UDI
Class IIActive
Ferritin AccuLite CLIA Test System - 96 Wells 2875-300
FDA UDI
Class IIActive
Monobind AccuLite Myoglobin CLIA Kit - 192 Wells 3275-300
FDA UDI
Class IIActive
T3 AccuLite CLIA Test System - 480 Wells 175-300
FDA UDI
Class IIActive
HSV 1+2 IgM AccuLite® CLIA Test System (6875-300A, 6875-300B) 6825-300
FDA UDI
Class IIActive
Monobind AccuBind Testosterone ELISA Kit - 192 Wells 3725-300
FDA UDI
Class IActive
Aldosterone AccuBind ELISA Test System - 192 Wells 10125-300
FDA UDI
Class IIActive
sTfR AccuLite CLIA Test System - 192 Wells 8675-300
FDA UDI
Class IIActive
DHEA-S AccuBind ELISA Test System - 96 Wells 5125-300
FDA UDI
Class IActive
hCG AccuBind ELISA Test System - 96 Wells 825-300
FDA UDI
Class IIActive
Vit D Direct AccuLite CLIA Test System - 960 wells 9475-300
FDA UDI
Class IIActive
PAPP-A AccuLite CLIA Test System - 96 Wells 12675-300
FDA UDI
N/AActive

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