FDA Registration
Active
🇺🇸 United States
MONOBIND, INC.
Reg #: 2020726
·
FEI: 2020726
·
Expires 2026
Products
65
Proprietary Names
244
Establishment Types
3
Classifications
65
Registration Details
- Registration Name
- MONOBIND, INC.
- Registration Number
- 2020726
- FEI Number
- 2020726
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100 N. POINTE DR.
- City
- Lake Forest
- State
- CA
- ZIP
- 92630
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020548
Owner / Operator
- Firm Name
- MONOBIND, INC.
- Operator Number
- 2020726
- Address
- 100 N. POINTE DR., --
- City
- Lake Forest
- State
- CA
- Postal Code
- 92630
- Country
- US
- Correspondent
- Alicia Jerome
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Biosensor, Immunoassay, Myoglobin | MVE | Class 2 | Immunology | No | 2010-09-21 |
| Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | NHX | Class 2 | Immunology | No | 2025-04-25 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2017-11-27 |
| Radioimmunoassay, Estrone | CGF | Class 1 | Clinical Chemistry | No | 2019-02-13 |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | Class 2 | Microbiology | No | 2022-04-20 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2010-04-12 |
| Newborn Screening Specimen Collection Paper | PJC | Class 2 | Clinical Chemistry | No | 2021-11-03 |
| Antigen, Inflammatory Response Marker, Sepsis | NTM | Class 2 | Microbiology | No | 2017-11-27 |
| Radioimmunoassay, Calcitonin | JKR | Class 2 | Clinical Chemistry | No | 2019-02-13 |
| Radioimmunoassay, Thyroxine-Binding Globulin | CEE | Class 2 | Clinical Chemistry | No | 2017-11-27 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2013-05-20 |
| Radioassay, Vitamin B12 | CDD | Class 2 | Clinical Chemistry | No | 2012-03-30 |
| Immunochemical, Thyroglobulin Autoantibody | JNL | Class 2 | Immunology | No | 2010-04-12 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2022-04-20 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-09-15 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2017-12-28 |
| Interleukin 6 | QLC | Class N | Unknown | No | 2022-04-16 |
| Radioimmunoassay, Human Growth Hormone | CFL | Class 1 | Clinical Chemistry | No | 2000-05-18 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2010-09-21 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2012-04-12 |
| System, Test, Thyroglobulin | MSW | Class 2 | Immunology | No | 2012-03-30 |
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2013-05-20 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2024-11-02 |
| Colorimetric Method, Cpk Or Isoenzymes | JHY | Class 2 | Clinical Chemistry | No | 2017-12-28 |
| Radioimmunoassay, Immunoglobulins (G, A, M) | CFQ | Class 2 | Immunology | No | 2010-09-21 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2010-09-21 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2010-04-12 |
| Radioimmunoassay (Two-Site Solid Phase), Ferritin | JMG | Class 2 | Immunology | No | 2010-09-21 |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | Class 1 | Clinical Chemistry | No | 2010-09-21 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2021-11-03 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2010-04-12 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2018-07-29 |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | Class 2 | Immunology | No | 2007-12-11 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 2010-09-21 |
| Radioimmunoassay, Acth | CKG | Class 2 | Clinical Chemistry | No | 2019-02-13 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2010-09-21 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2000-05-18 |
| Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | LTK | Class 2 | Immunology | No | 2007-12-11 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2010-09-21 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2010-04-12 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2010-04-12 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 2022-04-20 |
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 2010-09-21 |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | MXJ | Class 2 | Microbiology | No | 2022-04-20 |
| Thyroglobulin, Antigen, Antiserum, Control | DDC | Class 2 | Immunology | No | 2010-04-12 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2024-11-21 |
| Enzyme Immunoassay, Digoxin | KXT | Class 2 | Clinical Toxicology | No | 2010-09-21 |
| Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | NSF | Class 2 | Immunology | No | 2010-09-21 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 1992-10-26 |
| System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | NIG | Class 2 | Immunology | No | 2010-09-21 |
| Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | MTG | Class 3 | Unknown | No | 2021-11-02 |
| Radioimmunoassay, Estriol | CGI | Class 1 | Clinical Chemistry | No | 2010-09-21 |
| System, Test, Carcinoembryonic Antigen | DHX | Class 2 | Immunology | No | 2010-09-21 |
| Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | DAP | Class 2 | Hematology | No | 2020-09-15 |
| Radioimmunoassay, Androstenedione | CIZ | Class 1 | Clinical Chemistry | No | 2020-04-13 |
| Radioimmunoassay, Cortisol | CGR | Class 2 | Clinical Chemistry | No | 2010-09-21 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2010-09-21 |
| Radioimmunoassay, Aldosterone | CJM | Class 2 | Clinical Chemistry | No | 2019-02-13 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2024-01-19 |
| Anti-Müllerian Hormone Test System | PQO | Class 2 | Clinical Chemistry | No | 2020-09-15 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2007-12-11 |
| System, Test, Immunological, Antigen, Tumor | MOI | Class 2 | Immunology | No | 2010-09-21 |
| Radioimmunoassay, Parathyroid Hormone | CEW | Class 2 | Clinical Chemistry | No | 2017-11-27 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2024-05-28 |
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 2021-11-30 |
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)
PlateWash - Immunoassay Washer (IN002)
AutoPlex® ELISA Analyzer - Single Plate (IN006)
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)
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)
LH AccuLite® CLIA Test System(Ref 675-300A, 675-300B)
LH AccuBind® ELISA Test System (Ref 625-300A, 625-300B)
CA 19-9 AccuLite® CLIA Test System (Ref 3975-300A and 3975-300B)
CA 19-9 AccuBind® ELISA Test System (Ref 3925-300A and 3925-300B)
Free PSA AccuLite® CLIA Test System (Ref 2375-300A and 2375-300B)
Free PSA AccuBind® ELISA Test System (Ref 2325-300A and 2325-300B)
FT3 FT4 TSH AccuBind® VAST ELISA (7025-300B, 7025-300D, 7025-300E)
FT3 FT4 TSH AccuLite® VAST CLIA (7075-300B, 7075-300D, 7075-300E)
Free T4 AccuLite® CLIA Test System (1275-300A,1275-300B, 1275-300D, 1275-300E)
uE3 AccuLite® CLIA Test System (Ref 5075-300A, 5075-300B)
uE3 AccuBind® ELISA Test System (Ref 5025-300A, 5025-300B)
CEA AccuLite® CLIA Test System (Ref 1875-300A and 1875-300B
CEA AccuBind® ELISA Test System (Ref 1825-300A and 1825-300B)
CEA-Next Gen AccuBind® ELISA Test System (Ref 4625-300A and 4625-300B)
CEA-Next Gen AccuLite® CLIA Test System (Ref 4675-300A and 4675-300B)
D-Dimer AccuLite® CLIA Test System (Ref 12075-300A and 12075-300B)
D-Dimer AccuBind® ELISA Test System (Ref 12025-300A and 12025-300B)
ANST AccuLite® CLIA Test System (Ref 12475-300A, 12475-300B)
ANST AccuBind® ELISA Test System (Ref 12425-300A, 12425-300B)
Cortisol AccuLite® CLIA Test System (Ref 3675-300A and 3675-300B)
Cortisol AccuBind® ELISA Test System (Ref 3625-300A and 3625-300B)
C-Peptide AccuLite® CLIA Test System (Ref 2775-300A, 2775-300B)
C-Peptide AccuBind® ELISA Test System (Ref 2725-300A, 2725-300B)
C-Pep/ Ins VAST AccuLite® CLIA Test System (Ref 7375-300A, 7375-300B)
C-Pep/ Ins VAST AccuBind® ELISA Test System (Ref 7325-300A, 7325-300B)
TSH AccuBind® ELISA Test System (Ref 325-300A, 325-300B, 325-300D, 325-300E)
Aldosterone AccuLite® CLIA Test System (Ref 10175-300A and 10175-300B)
Aldosterone AccuBind® ELISA Test System (Ref 10125-300A and 10125-300B)
Anti-Tg & Anti-TPO QSure® Control - Positive & Negative (Ref AIT-101)
Tumor Marker QSure Control - Tri-Level (Ref TMC-300)
Maternal QSure® Control - Tri-Level (Ref MC-300)
Anti-H. Pylori QSure Control - Positive & Negative (Ref HPC-300)
Tg QSure® Control - Tri-Level (Ref TG-300)
TBG QSure® Control - Tri-Level (Ref TBG-300)
Multi-Ligand QSure® Control - Tri-Level (Ref ML-300, ML-300A, ML-300B)
AMH AccuBind® ELISA Test System (Ref 9725-300A and 9725-300B)
AMH AccuLite® CLIA Test System (Ref 9775-300A and 9775-300B)
Progesterone AccuBind® ELISA Test System (Ref 4825-300A, 4825-300B)
Progesterone AccuLite® CLIA Test System (Ref 4875-300A, 4875-300B)
CA 15-3 AccuLite® CLIA Test System (Ref 5675-300A and 5675-300B)
CA 15-3 AccuBind® ELISA Test System (Ref 5625-300A and 5625-300B)
T3U AccuBind® ELISA Test System (Ref 525-300A, 525-300B)
T3U AccuLite® CLIA Test System (Ref 575-300A 575-300B)
PTH Whole & Intact AccuBind® VAST ELISA Test System (Ref 10025-300A and 10025-300B)
PTH (Intact) 2nd Gen AccuLite® CLIA Test System (Ref 9075-300A and 9075-300B)
PTH Whole & Intact AccuLite® VAST CLIA Test System (Ref 10075-300A and 10075-300B)
PTH (Intact) 2nd Gen AccuBind® ELISA Test System (Ref 9025-300A and 9025-300B)
RF IgA AccuLite® CLIA Test System (Ref 13575-300A and 13575-300B)
RF IgG AccuBind® ELISA Test System (Ref 13625-300A and 13625-300B)
RF IgG AccuLite® CLIA Test System (Ref 13625-300A and 13675-300B)
RF IgM AccuBind® ELISA Test System (Ref 13425-300A and 13425-300B)
RF IgM AccuLite® CLIA Test System (Ref 13425-300A and 13475-300B)
RF IgA AccuBind® ELISA Test System (Ref 13525-300A and 13525-300B)
Testosterone AccuLite® CLIA Test System (Ref 3775-300A, 3775-300B)
Testosterone AccuBind® ELISA Test System (Ref 3725-300A, 3725-300B)
SHBG AccuLite® CLIA Test System (Ref 9175-300A and 9175-300B)
SHBG AccuBind® ELISA Test System (Ref 9125-300A and 9125-300B)
Free Testo AccuLite® CLIA Test System (Ref 5375-300A, 5375-300B)
0 Calibrator Steroid & Thyroid (T3-T4) Matrix (Ref 625MM)
Sample Dilient (hCG-Free) (Ref 8525145MM)
0 Calibrator FSH-Ferritin-Folate & Vitamin B12 Matrix (Ref 731MM)
Serum Diluent 10X (Anti-H. Pylori, Anti-Tg & Anti-TPO) (Ref 144MM)
0 Calibrator Multiligand Matrix (Ref 440MM)
T4-HS AccuBind® ELISA Test System (Ref 12825-300A, 12825-300B)
T4-SBS AccuBind® ELISA Test System (Ref 8225-300A, 8225-300B)
T4 AccuBind® ELISA Test System (Ref 225-300A, 225-300B, 225-300D, 225-300E)
T4-SBS AccuLite® CLIA Test System (Ref 8275-300A, 8275-300B)
T4 AccuLite® CLIA Test System (Ref 275-300A, 275-300B, 275-300D, 275-300E)
T4-Rapid AccuBind® ELISA Test System (Ref 11125-300A, 1125-300B)
T4 Canine AccuBind® ELISA Test System (12225-300A, 12225-300B)
Establishment Types
Manufacture Device in the United States for Export Only
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility