FDA Registration
Active
🇺🇸 United States
Immulite Analyzer
Reg #: 1036362
·
FEI: 1036362
·
Expires 2025
Products
59
Proprietary Names
1
Establishment Types
2
Classifications
59
Registration Details
- Registration Name
- SCIENTIFIC SUPPLIES & TECHNOLOGY, INC.
- Registration Number
- 1036362
- FEI Number
- 1036362
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 7245 N.W. 43RD ST.
- City
- Doral
- State
- FL
- ZIP
- 33166
- Country
- US
Regulatory Submissions
- 510(k) Number
- K022603
Owner / Operator
- Firm Name
- SST International Inc.
- Operator Number
- 1036362
- Address
- 7245 N.W. 43RD ST., --
- City
- Miami
- State
- FL
- Postal Code
- 33166
- Country
- US
- Correspondent
- PETER F LUE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Radioimmunoassay, Thyroxine-Binding Globulin | CEE | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2018-06-20 |
| System, Test, Radioallergosorbent (Rast) Immunological | DHB | Class 2 | Immunology | No | 2018-06-20 |
| Column Chromatography & Color Development, Hydroxyproline | JMM | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Ige, Peroxidase, Antigen, Antiserum, Control | DGO | Class 2 | Immunology | No | 2018-06-20 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| System, Test, Carcinoembryonic Antigen | DHX | Class 2 | Immunology | No | 2018-06-20 |
| Radioassay, Vitamin B12 | CDD | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2018-06-20 |
| Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | LTK | Class 2 | Immunology | No | 2018-06-20 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Radioimmunoassay, Cortisol | CGR | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2018-06-20 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2018-06-20 |
| Radioimmunoassay, Cyclic Gmp | CGT | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| System, Test, Thyroglobulin | MSW | Class 2 | Immunology | No | 2018-06-20 |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | Class 2 | Microbiology | No | 2018-06-20 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2018-06-20 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Urinary Homocystine (Nonquantitative) Test System | LPS | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Radioimmunoassay, Acth | CKG | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Enzyme Immunoassay, Valproic Acid | LEG | Class 2 | Clinical Toxicology | No | 2018-06-20 |
| System, Test, Beta-2-Microglobulin Immunological | JZG | Class 2 | Immunology | No | 2018-06-20 |
| Kit, Test,Alpha-Fetoprotein For Testicular Cancer | LOJ | Class 2 | Immunology | No | 2018-06-20 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| System, Test, Immunological, Antigen, Tumor | MOI | Class 2 | Immunology | No | 2018-06-20 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2018-06-20 |
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2018-06-20 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2018-06-20 |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | Class 2 | Immunology | No | 2018-06-20 |
| Radioimmunoassay, Immunoglobulins (D, E) | JHR | Class 2 | Immunology | No | 2018-06-20 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2018-06-20 |
| Albumin, Rhodamine, Antigen, Antiserum, Control | DFJ | Class 2 | Immunology | No | 2018-06-20 |
| Enzyme Immunoassay, Carbamazepine | KLT | Class 2 | Clinical Toxicology | No | 2018-06-20 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2018-06-20 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | LGC | Class 2 | Microbiology | No | 2018-06-20 |
| Enzyme Immunoassay, Digoxin | KXT | Class 2 | Clinical Toxicology | No | 2018-06-20 |
| Radioimmunoassay, Human Placental Lactogen | JMF | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Radioimmunoassay, Human Growth Hormone | CFL | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 2018-06-20 |
| Radioimmunoassay, Parathyroid Hormone | CEW | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Radioimmunoassay (Two-Site Solid Phase), Ferritin | JMG | Class 2 | Immunology | No | 2018-06-20 |
| Acid Phosphatase (Prostatic), Tartrate Inhibited | JFH | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Enzyme Immunoassay, Digitoxin | LFM | Class 2 | Clinical Toxicology | No | 2018-06-20 |
| Enzyme Immunoassay, Diphenylhydantoin | DIP | Class 2 | Clinical Toxicology | No | 2018-06-20 |
| Radioimmunoassay, Estriol | CGI | Class 1 | Clinical Chemistry | No | 2018-06-20 |
Proprietary Names
Immulite Analyzer
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device