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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 5 of 9
DeviceModel / ReferenceRegistriesClassStatus
Free T4 AccuBind ELISA Test System - 192 Wells 1225-300
FDA UDI
Class IIActive
0 Calibrator Matrix for FSH, Ferritin, Folate & Vit B12 731MM
FDA UDI
Class IActive
Toxo IgG AccuBind ELISA Test System - 192 Wells 6125-300
FDA UDI
Class IIActive
Monobind AccuBind hCG ELISA Kit - 192 Wells 825-300
FDA UDI
Class IIActive
Testosterone AccuLite CLIA Test System - 192 Wells 3775-300
FDA UDI
Class IActive
ACTH AccuLite CLIA Test System - 192 Wells 10675-300
FDA UDI
Class IIActive
T3 Uptake AccuLite CLIA Test System - 96 Wells 575-300
FDA UDI
Class IIActive
Monobind AccuLite AFP CLIA Kit - 192 Wells 1975-300
FDA UDI
Class IIActive
IgE AccuBind ELISA Test System - 960 Wells 2525-300
FDA UDI
Class IIActive
Monobind AccuLite T3, T4, TSH CLIA Kit - 2592 Wells 8075-300
FDA UDI
Class IIActive
TSH AccuLite CLIA Test System - 96 Wells 375-300
FDA UDI
Class IIActive
Vit B12 AccuBind ELISA Test System - 192 Wells 7625-300
FDA UDI
Class IIActive
SARS-CoV-2 IgG AccuBind ELISA Test System - 96 Wells 11925-300
FDA UDI
NActive
903 DBS Collection Cards - 5 Samples 621MM
FDA UDI
Class IIActive
T3 AccuLite CLIA Test System - 192 Wells 175-300
FDA UDI
Class IIActive
C-Peptide & Insulin Diabetes Panel AccuBind VAST ELISA Test System - 96 Wells 7325-300
FDA UDI
Class IActive
HSV 1+2 IgG AccuLite® CLIA Test System (6775-300A, 6775-300B) 6725-300
FDA UDI
Class IIActive
Monobind AccuBind Folate ELISA Kit - 192 Wells 7525-300
FDA UDI
Class IIActive
Folate, Vit B12 Anemia Panel AccuBind VAST ELISA Test System - 192 Wells 7875-300
FDA UDI
Class IIActive
Vit D Direct AccuLite CLIA Test System - 192 wells 9475-300
FDA UDI
Class IIActive
T3, T4, TSH Thyroid Panel AccuLite VAST AccuLite CLIA Test System - 480 Wells 8075-300
FDA UDI
Class IIActive
Monobind AccuLite Tg CLIA Kit - 96 Wells 2275-300
FDA UDI
Class IIActive
Monobind AccuBind T3 ELISA Kit - 96 Wells 125-300
FDA UDI
Class IIActive
FSH AccuBind ELISA Test System - 96 Wells 425-300
FDA UDI
Class IActive
Calcitonin AccuLite CLIA Test System - 96 Wells 9375-300
FDA UDI
Class IIActive
Vit B12 AccuLite CLIA Test System - 96 Wells 7675-300
FDA UDI
Class IIActive
PCT AccuBind ELISA Test System - 192 Wells 9225-300
FDA UDI
Class IIActive
ANST AccuBind ELISA Test System - 192 Wells 12425-300
FDA UDI
Class IActive
hCG Extended Range AccuBind ELISA Test System - 192 Wells 8825-300
FDA UDI
Class IIActive
Monobind AccuBind hCG Rapid ELISA Kit - 96 Wells 3325-300
FDA UDI
Class IIActive
T4 High Sensitivity AccuBind ELISA Test System - 96 wells 12825-300
FDA UDI
Class IIActive
903 DBS Collection Cards - 6 Samples 329MM
FDA UDI
Class IIActive
17OHP-SI AccuBind ELISA Test System - 192 Wells 9925-300
FDA UDI
Class IActive
T3, T4, TSH Thyroid Panel AccuLite VAST AccuLite CLIA Test System - 960 Wells 8075-300
FDA UDI
Class IIActive
C-Peptide & Insulin Diabetes Panel AccuLite VAST CLIA Test System - 96 Wells 7375-300
FDA UDI
Class IActive
IgE-XR AccuBind ELISA Test System - 96 Wells 13025-300
FDA UDI
Class IIActive
SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 96 Wells 12525-300
FDA UDI
NActive
N-TBG AccuBind ELISA Test System - 480 Wells 8925-300
FDA UDI
Class IIActive
PRL AccuLite CLIA Test System - 96 Wells 775-300
FDA UDI
Class IActive
uE3 AccuBind ELISA Test System - 192 Wells 5025-300
FDA UDI
Class IActive
PTH Intact AccuLite CLIA Test System - 192 Wells 9075-300
FDA UDI
Class IIActive
Free T3, Free T4, TSH Thyroid Panel AccuBind VAST ELISA Test System - 192 Wells 7025-300
FDA UDI
Class IIActive
IGF-1 AccuBind ELISA Test System - 96 Wells 13325-300
FDA UDI
Class IActive
cTnI AccuLite CLIA Test System - 96 Wells 3875-300
FDA UDI
Class IIActive
hGH AccuBind ELISA Test System - 192 Wells 1725-300B
FDA UDI
Class IActive
Free T3, Free T4, TSH Thyroid Panel AccuBind VAST ELISA Test System - 480 Wells 7025-300
FDA UDI
Class IIActive
Aldosterone AccuLite CLIA Test System - 96 Wells 10175-300
FDA UDI
Class IIActive
Monobind AccuLite hCG CLIA Kit - 192 Wells 875-300
FDA UDI
Class IIActive
17OHP AccuLite CLIA Test System - 96 Wells 5275-300
FDA UDI
Class IActive
Ferritin AccuLite CLIA Test System - 192 Wells 2875-300
FDA UDI
Class IIActive

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