Contract manufacturerNOVA BIOMEDICAL CORPORATION (Waltham, MA)MassachusettsClinical chemistryHematologyClass IIClass IClass III
NOVA BIOMEDICAL CORPORATION
Contract manufacturer ยท Waltham, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1219029 (openFDA record; or search FDA's registration database)
- FEI number
- 1219029
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Remanufacturer; Repackager or relabeler
- Owner or operator
- NOVA BIOMEDICAL CORP. (FDA owner/operator no. 1219029)
- Registered address
- 200 Prospect St, Waltham, MA 02454
- Contract listings
- 19 device listings, 18 product codes, first listed Sep 21, 2006
- 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 |
|---|---|---|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | Class II | Clinical chemistry | Contract manufacturing | Dec 13, 2013 |
| CGA | Glucose Oxidase, Glucose | Class II | Clinical chemistry | Contract manufacturing | Oct 19, 2007 |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | Class II | Clinical chemistry | Contract manufacturing | Oct 19, 2007 |
| CGZ | Electrode, Ion-Specific, Chloride | Class II | Clinical chemistry | Contract manufacturing | Dec 13, 2013 |
| CIG | Diazo Colorimetry, Bilirubin | Class II | Clinical chemistry | Contract manufacturing | Sep 21, 2006 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | Class II | Clinical chemistry | Contract manufacturing | Dec 13, 2013 |
| JGS | Electrode, Ion Specific, Sodium | Class II | Clinical chemistry | Contract manufacturing | Dec 13, 2013 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Class I | Clinical chemistry | Contract manufacturing | Nov 26, 2010 |
| JIT | Calibrator, Secondary | Class II | Clinical chemistry | Contract manufacturing | Sep 21, 2006 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Class I | Clinical chemistry | Contract manufacturing | Dec 11, 2013 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Class I | Clinical chemistry | Contract manufacturing | Oct 19, 2007 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Class I | Clinical chemistry | Contract manufacturing | Sep 21, 2006 |
| KHP | Acid, Lactic, Enzymatic Method | Class I | Clinical chemistry | Contract manufacturing | Dec 2, 2011 |
| LFR | Glucose Dehydrogenase, Glucose | Class II | Clinical chemistry | Contract manufacturing | Oct 28, 2013 |
| NBW | System, Test, Blood Glucose, Over The Counter | Class II | Clinical chemistry | Contract manufacturing | Oct 19, 2007 |
| PJF | Illuminator System For Blood Products | Class III | Hematology | Contract manufacturing | Jan 5, 2015 |
| PTC | Uric Acid Test System For At Home Prescription Use | Class I | Clinical chemistry | Contract manufacturing | May 11, 2017 |
| PZI | Prescription Use Blood Glucose Meter For Near-Patient Testing | Class II | Clinical chemistry | Contract manufacturing | Jan 15, 2015 |