MONOBIND, INC.

FDA Device Registration & Listing · Lake Forest, CA, US · Registration 2020726

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2020726
FEI Number
2020726
Entity Name
MONOBIND, INC.
City/State/Country
Lake Forest, CA, US
Establishment Address
100 N. POINTE DR., Lake Forest, CA 92630, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MONOBIND, INC. (Owner Number: 2020726)
Owner / Operator Contact Address
100 N. POINTE DR., --, Lake Forest, CA 92630, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Myoglobin AccuBind® ELISA Test System (Ref 3225-300A and 3225-300B) Myoglobin AccuLite® CLIA Test System (Ref 3275-300A and 3275-300B) Anti-CCP IgG AccuLite® CLIA Test System (Refs 12775-300A 12775-300B) Anti-CCP IgG AccuBind® ELISA Test System (Refs 12725-300A 12725-300B) Vit D Direct AccuBind® ELISA Test System (Ref 9425-300A and 9425-300B and 9425-300D and 9425-300E) Vit D Direct AccuLite® CLIA Test System (Ref 9475-300A and 9475-300B and 9475-300D and 9475-300E) E1 AccuBind® ELISA Test System (Ref 10325-300A, 10325-300B) E1 AccuLite® CLIA Test System (Ref 10375-300A, 10375-300B) CMV IgG AccuLite® CLIA Test System (Ref 6575-300A and 6525-300B) CMV IgM AccuLite® CLIA Test System (Ref 6675-300A and 6675-300B) CMV IgM AccuBind® ELISA Test System (Ref 6625-300A and 6625-300B) CMV IgG AccuBind® ELISA Test System (Ref 6525-300A and 6525-300B) Free T4 AccuLite® CLIA Test System (Ref 1275-300A, 1275-300B, 1275-300D, 1275-300E) Free T4 AccuBind® ELISA Test System (Ref 1225-300A, 1225-300B, 1225-300D, 1225-300E) 903 DBS Collection Cards - 5 Samples (Ref 621MM) 903 DBS Collection Cards - 6 Samples (Ref 329MM) PCT AccuBind® ELISA Test System (Ref 9225-300A and 9225-300B) PCT AccuLite® CLIA Test System (Ref 9275-300A and 9275-300B) Calcitonin AccuBind® ELISA Test System (Ref 9325-300A and 9325-300B) Calcitonin AccuLite® CLIA Test System (Ref 9375-300A and 9375-300B N-TBG AccuBind® ELISA Test System (Ref 8925-300A, 8925-300B) TBG AccuLite® CLIA Test System (Ref 3575-300A and 3575-300B) TBG AccuBind® ELISA Test System (Ref 3525-300A. 3525-300B) Folate AccuLite® CLIA Test System (Ref 7575-300A and 7575-300B) Folate AccuBind® ELISA Test System (Ref 7525-300A and 7525-300B) Vit B12 AccuLite® CLIA Test System (Ref 7675-300A and 7675-300B) Folate/ Vit B12 VAST AccuBind® ELISA Test System (Ref 7825-300A and 7825-300B) Folate/ Vit B12 VAST AccuLite® CLIA Test System (Ref 7875-300A and 7875-300B) Vit B12 AccuBind® ELISA Test System (Ref 7625-300A and 7625-300B) Anti-Tg AccuLite® CLIA Test System (Ref 1075-300A, 1075-300B) Anti-Tg AccuBind® ELISA Test System (Ref 1025-300A, 1025-300B) Rubella IgG AccuLite® CLIA Test System (Ref 6375-300A and 6375-300B) Rubella IgM AccuBind® ELISA Test System (Ref 6425-300A and 6425-300B) Rubella IgM AccuLite® CLIA Test System (Ref 6475-300A and 6475-300B) Rubella IgG AccuBind® ELISA Test System (Ref 6325-300A and 6325-300B) COVID-19 IgM AccuLite® CLIA Test System (Ref 11775-300A and 11775-300B) COVID-19 IgG S1-RBD AccuLite® CLIA Test System (Ref 12575-300A and 12575-300B) COVID-19 IgG S1-RBD AccuBind® ELISA Test System (Ref 12525-300A and 12525-300B) COVID-19 IgA AccuBind® ELISA Test System (Ref 11825-300A and 11825-300B) COVID-19 IgA AccuLite® CLIA Test System (Ref 11875-300A and 11875-300B) COVID-19 IgG AccuBind® ELISA Test System (Ref 11925-300A and 11925-300B) COVID-19 IgG AccuLite® CLIA Test System (Ref 11975-300A and 11975-300B) COVID-19 IgM AccuBind® ELISA Test System (Ref 11725-300A and 11725-300B) cTnI AccuLite® CLIA Test System (Ref 3875-300A and 3875-300B) cTnI AccuBind® ELISA Test System (Ref 3825-300A and 3825-300B) IL-6 AccuLite® CLIA Test System (Ref 13275-300A and 13275-300B) IL-6 AccuBind® ELISA Test System (Ref 13225-300A and 13225-300B) IGF-1 AccuLite® CLIA Test System (Ref 13375-300A, 13375-300B) hGH AccuBind® ELISA Test System (Ref 1725-300A, 1725-300B) IGF-1 AccuBind® ELISA Test System (Ref 13325-300A, 13325-300B) hGH AccuLite® CLIA Test System (Ref 1775-300A, 1775-300B) Hs-CRP AccuBind® ELISA Test System (Ref 3125-300A and 3125-300B) Hs-CRP AccuLite® CLIA Test System (Ref 3175-300A and 3175-300B) PrisMatic® ELISA Analyzer (IN013) LuMatic® CLIA Analyzer (IN008) NeoLumax® CLIA Analyzer (IN010) Autoplex® ELISA Analyzer & CLIA Processor (IN006) NeoEldex® ELISA Analyzer (IN009) Impulse3® CLIA Analyzer (IN007) TITIN-s® ELISA & CLIA Analyzer (IN016-EC) TITIN-s® ELISA Analyzer (IN016-E) Immunoassay Plate Washer (IN002) Autoplex® 3rd Generation ELISA & CLIA Analyzer (IN006-3) TITIN® ELISA & CLIA Analyzer (IN015-EC) Autoplex® 2nd Generation ELISA & CLIA Analyzer (IN006-2) TITIN® ELISA Analyzer (IN016-E) Tg AccuBind® ELISA Test System (Ref 2225-300A and 2225-300B) Tg AccuLite® CLIA Test System (Ref 2275-300A and 2275-300B) sTfR AccuLite® CLIA Test System (Ref 8675-300A and 8675-300B) sTfR AccuBind® ELISA Test System (Ref 8625-300A and 8625-300B) NeoEldex® ELISA Analyzer Touch Screen (IN009) NeoLumax® CLIA Analyzer Touch Screen (IN010) LuMatic® CLIA Analyzer (IN008) PlateWash - Immunoassay Washer (IN002) AutoPlex® ELISA Analyzer - Single Plate (IN006) PrisMatic® ELISA Analyzer (IN013) ELISA CLIA Analyzer System AutoPlex® ELISA & CLIA Analyzer 2nd Generation- Single Plate (IN006-2) AutoPlex® ELISA & CLIA Analyzer 3rd Generation- Two Plate (IN006-3) CK-MB AccuBind® ELISA Test System (Ref 2925-300A and 2925-300B) CK-MB AccuLite® CLIA Test System (Ref 2975-300A and 2975-300B) IgE AccuBind® ELISA Test System (Ref 2525-300A and 2525-300B) IgE-XR AccuBind® ELISA Test System (13025-300A, 13025-300B) IgE AccuLite® CLIA Test System (Ref 2575-300A and 2575-300B) PAPP-A AccuLite® CLIA Test System (Ref 12675-300A and 12675-300B) PAPP-A AccuBind® ELISA Test System (Ref 12625-300A and 12625-300B) HCG AccuLite® CLIA Test System (Ref 875-300A and 875-300B) Free ?-hCG AccuBind® ELISA Test System (Ref 2025-300A and 2025-300B) HCG Rapid AccuBind® ELISA Test System (Ref 3325-300A and 3325-300B) HCG AccuBind® ELISA Test System (Ref 825-300A and 825-300B) HCG-XR AccuLite® CLIA Test System (Ref 8875-300A and 8875-300B) Free ?-hCG AccuLite® CLIA Test System (Ref 2075-300A and 2075-300B) HCG-XR AccuBind® ELISA Test System (Ref 8825-300A and 8825-300B) PRL AccuLite® CLIA Test System (Ref 775-300A, 775-300B) PRLs AccuBind® ELISA Test System(Ref 4425-300A, 4425-300B) PRLs AccuLite® CLIA Test System (Ref 4475-300A, 4475-300B) PRL AccuBind® ELISA Test System (Ref 725-300A, 725-300B) Ferritin AccuBind® ELISA Test System (Ref 2825-300A and 2825-300B) Ferritin AccuLite® CLIA Test System (Ref 2875-300A and 2875-300B) PRLs AccuBind® ELISA Test System (4425-300A, 4425-300B) PRL AccuBind® ELISA Test System (725-300A, 725-300B) PRL AccuLite® CLIA Test System (775-300A, 775-300B) PRLs AccuLite® CLIA Test System (4475-300A, 4475-300B) 17-OHP-SI AccuLite® CLIA Test System (Ref 9975-300A, 9975-300B) 17-OHP AccuLite® CLIA Test System (Ref 5275-300A, 5275-300B) 17-OHP-SI AccuBind® ELISA Test System (Ref 9925-300A, 9925-300B) N-17-OHP AccuBind® ELISA Test System (Ref 5525-300A, 5525-300B, 5525-300D, 5525-300E, 5525-300F) 17-OHP AccuBind® ELISA Test System (Ref 5225-300A, 5225-300B) TSH-Rapid AccuLite® CLIA Test System (Ref 6075-300A, 6075-300B) T3/ T4/ TSH VAST AccuLite® CLIA Test System (Ref 8075-300A, 8075-300B, 8075-300D, 8075-300E) TSH-Rapid AccuBind® ELISA Test System (Ref 6025-300A, 6025-300B) TSH AccuLite® CLIA Test System (Ref 375-300A, 375-300B, 375-300D, 375-300E) T3/ T4/ TSH VAST AccuBind® ELISA Test System (Ref 8025-30A, 8025-300B, 8025-300D, 8025-300E) FSH AccuBind® ELISA Test System (Ref 425-300A, 425-300B) FSH/ hCG/ LH/ PRLs VAST AccuLite® CLIA Test System (Ref 8375-300A, 8375-300B, 8375-300D, 8375-300E) FSH/ hCG/ LH/ PRLs VAST AccuBind® ELISA Test System (Ref 8325-300A, 8325-300B, 8325-300D, 8325-300E) FSH AccuLite® CLIA Test System (Ref 475-300A, 475-300B) Free Testo AccuBind® ELISA Test System (Ref 5325-300A, 5325-300B) FSH AccuBind® ELISA Test System (425-300A, 425-300B) FSH AccuLite® CLIA Test System (475-300A, 475-300B) FSH, hCG, LH, PRLs Fertility Panel AccuBind® VAST ELISA Test System (8325-300A, 8325-300B) FSH, hCG, LH, PRLs Fertility Panel AccuLite® VAST CLIA Test System (8375-300A, 8375-300B) PSA AccuLite® CLIA Test System (Ref 2175-300A and 2175-300B) PSA-XS AccuLite® CLIA Test System (Ref 8775-300A and 8775-300B) PSA-XS AccuBind® ELISA Test System (Ref 8725-300A and 8725-300B) PSA AccuBind® ELISA Test System (Ref 2125-300A and 2125-300B) DHEA AccuLite® CLIA Test System (Ref 7475-300A, 7475-300B) DHEA-S AccuBind® ELISA Test System (Ref 5125-300A, 5125-300B) DHEA-S AccuLite® CLIA Test System (Ref 5175-300A, 5175-300B) DHEA AccuBind® ELISA Test System (Ref 7425-300A, 7425-300B) ACTH AccuBind® ELISA Test System (Ref 10625-300A and 10625-300B) ACTH AccuLite® CLIA Test System (Ref 10675-300A and 10675-300B) Anti-H. Pylori IgG AccuLite® CLIA Test System (Ref 1475-300A and 1475-300B) Anti-H. Pylori IgM AccuBind® ELISA Test System (Ref 1525-300A and 1525-300B) Anti-H. Pylori IgM AccuLite® CLIA Test System (Ref 1575-300A and 1575-300B) Anti-H. Pylori IgA AccuBind® ELISA Test System (Ref 1625-300A and 1625-300B) Anti-H. Pylori IgG AccuBind® ELISA Test System (Ref 1425-300A and 1425-300B) Anti-H. Pylori IgA AccuLite® CLIA Test System (Ref 1675-300A and 1675-300B) N-TSH AccuBind® ELISA Test System (Ref 3425-300A, 3425-300B, 3425-300D, 3425-300E, 3425-300F) T3 Uptake AccuBind® ELISA Test System (525-300A, 525-300B) T3 Uptake AccuLite® CLIA Test System (575-300A, 575-300B) CA-125 AccuBind® ELISA Test System (Ref 3025-300A and 3025-300B) CA-125 AccuLite® CLIA Test System (Ref 3075-300A and 3075-300B) E2 AccuLite® CLIA Test System (Ref 4975-300A, 4975-300B) E2 AccuBind® ELISA Test System (Ref 4925-300A, 4925-300B) T3-Rapid AccuBind® ELISA Test System (Ref 11225-300A, 11225-300B) T3 AccuBind® ELISA Test System (Ref 125-300A, 125-300B, 125-300D, 125-300E) T3-SBS AccuBind® ELISA Test System (Ref 8125-300A, 8125-300B) T3 AccuLite® CLIA Test System (Ref 175-300A, 175-300B, 175-300D, 175-300E) T3-SBS AccuLite® CLIA Test System (Ref 8175-300A, 8175-300B) N-T4 AccuBind® ELISA Test System (Ref 2625-300A, 2625-300B, 2625-300D, 2625-300E, 2625-300F) Toxoplasma IgM AccuBind® ELISA Test System (Ref 6225-300A and 6225-300B) Toxoplasma IgM AccuLite® CLIA Test System (Ref 6275-300A and 6275-300B) Toxoplasma IgG AccuLite® CLIA Test System (Ref 6175-300A and 6175-300B) Toxoplasma IgG AccuBind® ELISA Test System (Ref 6125-300A and 6125-300B) Insulin AccuBind® ELISA Test System (Ref 2425-300A, 2425-300B) Insulin AccuLite® CLIA Test System (Ref 2475-300A, 2475-300B) Rapid Insulin AccuBind® ELISA Test System (Ref 5825-300A, 5825-300B) HSV 1+2 IgG AccuLite® CLIA Test System (Ref 6775-300A and 6775-300B) HSV 1+2 IgM AccuLite® CLIA Test System (Ref 6875-300A and 6875-300B) HSV 1+2 IgG AccuBind® ELISA Test System (Ref 6725-300A and 6725-300B) HSV 1+2 IgM AccuBind® ELISA Test System (Ref 6825-300A and 6825-300B) Anti-TPO AccuLite® CLIA Test System (Ref 1175-300A, 1175-300B) Anti-TPO AccuBind® ELISA Test System(Ref 1125-300A, 1125-300B) PlateWash - Immunoassay Washer (IN002) Digoxin AccuBind® ELISA Test System (Ref 925-300A and 925-300B) Digoxin AccuLite® CLIA Test System (Ref 975-300A and 975-300B) AFP/ CEA/ PSA VAST AccuLite® CLIA Test System (Ref 8475-300A and 8475-300B and 8475-300D and 8475-300E) AFP/ hCG/ uE3 VAST AccuLite® CLIA Test System (Ref 8575-300A and 8575-300B and 8575-300D and 8575-300E) AFP AccuBind® ELISA Test System (Ref 1925-300A and 1925-300B) AFP/ CEA/ PSA VAST AccuBind® ELISA Test System (Ref 8425-300A and 8425-300B and 8425-300D and 8425-300E) AFP AccuLite® CLIA Test System (Ref 1975-300A and 1975-300B) AFP/ hCG/ uE3 VAST AccuBind® ELISA Test System (Ref 8525-300A and 8525-300B and 8525-300D and 8525-300E) Free T3/ Free T4/ TSH VAST AccuBind® ELISA (Ref 7025-300A, 7025-300B, 7025-300D, 7025-300E) Free T3/ Free T4/ TSH VAST AccuLite® CLIA (Ref 7075-300A, 7075-300B, 7075-300D, 7075-300E) Free T3 AccuLite® CLIA Test System (Ref 1375-300A, 1375-300B, 1375-300D, 1375-300E) Free T3 AccuBind® ELISA Test System (Ref 1325-300A, 1325-300B, 1325-300D, 1325-300E)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MVE Biosensor, Immunoassay, Myoglobin Immunology Class 2 866.5680 2010-09-21
NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) Immunology Class 2 866.5775 2025-04-25
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2017-11-27
CGF Radioimmunoassay, Estrone Clinical Chemistry Class 1 862.1280 2019-02-13
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2022-04-20
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2010-04-12
PJC Newborn Screening Specimen Collection Paper Clinical Chemistry Class 2 862.1675 2021-11-03
NTM Antigen, Inflammatory Response Marker, Sepsis Microbiology Class 2 866.3210 2017-11-27
JKR Radioimmunoassay, Calcitonin Clinical Chemistry Class 2 862.1140 2019-02-13
CEE Radioimmunoassay, Thyroxine-Binding Globulin Clinical Chemistry Class 2 862.1685 2017-11-27
CGN Acid, Folic, Radioimmunoassay Clinical Chemistry Class 2 862.1295 2013-05-20
CDD Radioassay, Vitamin B12 Clinical Chemistry Class 2 862.1810 2012-03-30
JNL Immunochemical, Thyroglobulin Autoantibody Immunology Class 2 866.5870 2010-04-12
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2022-04-20
QKO Reagent, Coronavirus Serological Unknown Class N N/A 2020-09-15
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2017-12-28
QLC Interleukin 6 Unknown Class N N/A 2022-04-16
CFL Radioimmunoassay, Human Growth Hormone Clinical Chemistry Class 1 862.1370 2000-05-18
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2010-09-21
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use Clinical Chemistry Class 1 862.2300 2012-04-12
MSW System, Test, Thyroglobulin Immunology Class 2 866.6010 2012-03-30
DDG Transferrin, Antigen, Antiserum, Control Immunology Class 2 866.5880 2013-05-20
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2024-11-02
JHY Colorimetric Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2017-12-28
CFQ Radioimmunoassay, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2010-09-21
DHA System, Test, Human Chorionic Gonadotropin Clinical Chemistry Class 2 862.1155 2010-09-21
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 2010-04-12
JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin Immunology Class 2 866.5340 2010-09-21
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 1992-10-26
JLX Radioimmunoassay, 17-Hydroxyprogesterone Clinical Chemistry Class 1 862.1395 2010-09-21
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2021-11-03
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 2010-04-12
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2018-07-29
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 1992-10-26
LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology Class 2 866.6010 2007-12-11
JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) Clinical Chemistry Class 1 862.1245 2010-09-21
CKG Radioimmunoassay, Acth Clinical Chemistry Class 2 862.1025 2019-02-13
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2010-09-21
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2010-04-12
KHQ Radioassay, Triiodothyronine Uptake Clinical Chemistry Class 2 862.1715 2000-05-18
LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) Immunology Class 2 866.6010 2007-12-11
CHP Radioimmunoassay, Estradiol Clinical Chemistry Class 1 862.1260 2010-09-21
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 2010-04-12
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine Clinical Chemistry Class 2 862.1700 2010-04-12
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2022-04-20
CFP Radioimmunoassay, Immunoreactive Insulin Clinical Chemistry Class 1 862.1405 2010-09-21
MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 Microbiology Class 2 866.3305 2022-04-20
DDC Thyroglobulin, Antigen, Antiserum, Control Immunology Class 2 866.5870 2010-04-12
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2024-11-21
KXT Enzyme Immunoassay, Digoxin Clinical Toxicology Class 2 862.3320 2010-09-21
NSF Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment Immunology Class 2 866.6030 2010-09-21
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 1992-10-26

Official Correspondent

Alicia Jerome

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MONOBIND, INC.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2020726. Last updated year: 2026. Please use registration number 2020726 when referencing this establishment in official correspondence.
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