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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 3 of 9
DeviceModel / ReferenceRegistriesClassStatus
E2 AccuLite CLIA Test System - 192 Wells 4975-300
FDA UDI
Class IActive
Monobind AccuBind TBG ELISA Kit - 96 Wells 3525-300
FDA UDI
Class IIActive
FSH, hCG, LH & PRLs VAST AccuBind ELISA Test System - 480 Wells 8325-300
FDA UDI
Class IActive
Folate AccuLite CLIA Test System -192 Wells 7575-300
FDA UDI
Class IIActive
N-T4 AccuBind ELISA Test System - 192 Wells 2625-300
FDA UDI
Class IIActive
T4 SBS AccuBind ELISA Test System - 192 Wells 8225-300
FDA UDI
Class IIActive
Monobind AccuLite hCG CLIA Kit - 96 Wells 875-300
FDA UDI
Class IIActive
T4 SBS AccuBind ELISA Test System - 96 Wells 8225-300
FDA UDI
Class IIActive
IL-6 AccuBind ELISA Test System - 96 Wells 13225-300
FDA UDI
NActive
Myoglobin AccuBind ELISA Test System - 192 Wells 3225-300
FDA UDI
Class IIActive
IL-6 AccuBind ELISA Test System - 192 Wells 13225-300
FDA UDI
NActive
Monobind AccuLite TBG CLIA Kit - 96 Wells 3575-300
FDA UDI
Class IIActive
C-Peptide AccuBind ELISA Test System - 96 Wells 2725-300
FDA UDI
Class IActive
Progesterone AccuBind ELISA Test System - 192 Wells 4825-300
FDA UDI
Class IActive
D-Dimer AccuBind ELISA Test System - 96 Wells 12025-300
FDA UDI
Class IIActive
Monobind AccuBind SHBG ELISA Kit - 96 Wells 9125-300
FDA UDI
Class IActive
Vit B12 AccuBind ELISA Test System - 96 Wells 7625-300
FDA UDI
Class IIActive
HSV 1+2 IgM AccuBind® ELISA Test System (6825-300A, 6825-300B) 6825-300
FDA UDI
Class IIActive
N-T4 AccuBind ELISA Test System - 96 Wells 2625-300
FDA UDI
Class IIActive
Insulin Rapid AccuBind ELISA Test System - 192 Wells 5825-300
FDA UDI
Class IActive
Anti-H. Pylori IgA AccuLite CLIA Test System - 96 Wells 1675-300
FDA UDI
Class IActive
Anti-Tg AccuBind ELISA Test System - 96 Wells 1025-300
FDA UDI
Class IIActive
AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 96 Wells 8525-300
FDA UDI
Class IIActive
TSH AccuLite CLIA Test System - 192 Wells 375-300
FDA UDI
Class IIActive
Tg AccuBind ELISA Test System - 96 Wells 2225-300
FDA UDI
Class IIActive
E2 AccuLite CLIA Test System - 96 Wells 4975-300
FDA UDI
Class IActive
SARS-CoV-2 IgG AccuBind ELISA Test System - 192 Wells 11925-300
FDA UDI
NActive
Insulin AccuLite CLIA Test System - 96 Wells 2475-300
FDA UDI
Class IActive
Anti-H. Pylori IgM AccuBind ELISA Test System - 96 Wells 1425-300
FDA UDI
Class IActive
Monobind AccuLite CKMB CLIA Kit - 96 Wells 2975-300
FDA UDI
Class IIActive
IGF-1 AccuLite CLIA Test System - 192 Wells 13375-300
FDA UDI
Class IActive
Monobind Qsure TBG Control Set TBG-300
FDA UDI
Class IActive
IgE AccuBind ELISA Test System - 96 Wells 2525-300
FDA UDI
Class IIActive
IL-6 AccuLite CLIA Test System - 96 Wells 13275-300
FDA UDI
NActive
TSH AccuBind ELISA Test System - 960 Wells 325-300
FDA UDI
Class IIActive
Toxo IgM AccuBind ELISA Test System - 192 Wells 6225-300
FDA UDI
Class IIActive
AFP AccuLite CLIA Test System - 96 Wells 1975-300
FDA UDI
Class IIActive
T4 AccuLite CLIA Test System - 480 Wells 275-300
FDA UDI
Class IIActive
PRLs AccuLite CLIA Test System - 96 Wells 4475-300
FDA UDI
Class IActive
CMV IgM AccuBind ELISA Test System - 192 Wells 6625-300
FDA UDI
Class IIActive
Total PSA AccuLite CLIA Test System - 96 Wells 2175-300
FDA UDI
Class IIActive
PTH Whole & Intact AccuBind VAST ELISA Test System - 96 Wells 10025-300
FDA UDI
Class IIActive
Cortisol AccuLite CLIA Test System - 96 Wells 3675-300
FDA UDI
Class IIActive
Folate, Vit B12 Anemia Panel AccuBind VAST ELISA Test System - 96 Wells 7875-300
FDA UDI
Class IIActive
Monobind Qsure Tg Control Set TG-300
FDA UDI
Class IActive
DHEA AccuLite CLIA Test System - 96 Wells 7475-300
FDA UDI
Class IActive
Free T4 AccuLite CLIA Test System - 192 Wells 1275-300
FDA UDI
Class IIActive
Monobind AccuBind T3 ELISA Kit - 480 Wells 125-300
FDA UDI
Class IIActive
CK-MB AccuBind ELISA Test System - 192 Wells 2925-300
FDA UDI
Class IIActive
IgE AccuLite CLIA Test System - 192 Wells 2575-300
FDA UDI
Class IIActive

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