MAUDE manufacturer profile
CEPHEID · NJR
MAUDE profile for Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Key facts
| Manufacturer | CEPHEID |
|---|---|
| Manufacturer group | CEPHEID |
| Product code | NJR |
| Product code name | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- False Negative Result, Adverse Event Without Identified Device or Use Problem, Meningitis, Septic Shock, Sepsis, Respiratory Distress Syndrome of Newborns, Feeding Problem, Pulmonary Dysfunction Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1