Contract manufacturerDIAMOND DIAGNOSTICS Inc (Holliston, MA)MassachusettsClinical chemistryHematologyMicrobiologyClass IClass II
DIAMOND DIAGNOSTICS Inc
Contract manufacturer ยท Holliston, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3003030793 (openFDA record; or search FDA's registration database)
- FEI number
- 3003030793
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- Diamond Diagnostics Inc. (FDA owner/operator no. 10028706)
- Registered address
- 333 Fiske St, Holliston, MA 01746
- Contract listings
- 6 device listings, 21 product codes, first listed Nov 11, 2011
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | Class I | Clinical chemistry | Contract manufacturing | Dec 27, 2024 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | Class II | Hematology | Contract manufacturing | Dec 27, 2024 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | Class II | Clinical chemistry | Contract manufacturing | Dec 27, 2024 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Class I | Clinical chemistry | Contract manufacturing | Nov 11, 2011 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | Class II | Clinical chemistry | Contract manufacturing | Dec 27, 2024 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | Class II | Clinical chemistry | Contract manufacturing | Dec 27, 2024 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | Class II | Microbiology | Contract manufacturing | Dec 27, 2024 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | Class II | Microbiology | Contract manufacturing | Dec 27, 2024 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Class II | Microbiology | Contract manufacturing | May 1, 2014 |
| LSR | Reagent, Borrelia Serological Reagent | Class II | Microbiology | Contract manufacturing | Dec 27, 2024 |
| LYR | Helicobacter Pylori | Class I | Microbiology | Contract manufacturing | Dec 27, 2024 |
| MDB | System, Blood Culturing | Class I | Microbiology | Contract manufacturing | Dec 27, 2024 |
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | Class II | Microbiology | Contract manufacturing | Dec 27, 2024 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | Class II | Microbiology | Contract manufacturing | Dec 27, 2024 |
| OEM | Human Metapneumovirus (Hmpv) Rna Assay System | Class II | Microbiology | Contract manufacturing | Dec 27, 2024 |
| OEP | Influenza A Virus Subtype Differentiation Nucleic Acid Assay | Class II | Microbiology | Contract manufacturing | Dec 27, 2024 |
| OOI | Real Time Nucleic Acid Amplification System | Class II | Clinical chemistry | Contract manufacturing | Dec 27, 2024 |
| OOU | Parainfluenza Multiplex Nucleic Acid Assay | Class II | Microbiology | Contract manufacturing | Dec 27, 2024 |
| OTG | Non-Sars Coronavirus Multiplex Nucleic Acid Assay | Class II | Microbiology | Contract manufacturing | Dec 27, 2024 |
| OZX | Mycoplasma Pneumoniae Dna Assay System | Class II | Microbiology | Contract manufacturing | Dec 27, 2024 |
| OZZ | Bordetella Pertussis Dna Assay System | Class II | Microbiology | Contract manufacturing | Dec 27, 2024 |