Data / Medical devices / Prescription Use Blood Glucose Meter For Near-Patient Testing
Prescription Use Blood Glucose Meter For Near-Patient Testing (PZI): 6 FDA-registered makers in 4 countries
6 establishments in 4 countries are registered with the FDA to make Prescription Use Blood Glucose Meter For Near-Patient Testing (product code PZI, Class 2, 21 CFR 862.1345). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on June 12, 2026, and lists 2 recall events (2 Class I). FDA data exported November 3, 2026.
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- Product code
- PZI
- Device class
- 2
- Regulation
- 862.1345
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Philippines | 1 |
| Japan | 1 |
| Taiwan | 1 |
Makers of Prescription Use Blood Glucose Meter For Near-Patient Testing
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Nova Biomedical Corporation | Waltham, MA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer | 5 | February 23, 2024 | 0 | 2 | 2 | api.fda.gov |
| Nova Biomedical Corporation Diabetes Products | Billerica, MA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 5 | February 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nova Biomedical Corporation | Billerica, MA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer | 5 | February 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| ARKRAY Industry West Inc. | Rosario Cavite, Philippines | Manufacturer | 1 | May 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| Arkray, Inc. | Kamigyo-ku Kyoto, Japan | Specification developer | 1 | May 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| Apex Biotechnology Corp. | HSINCHU Hsinchu(County), Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.