CORONAVIRUS [obsolete from 2025-01-01]
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Basic Information
- Primary DI
- 08800069141018
- Basic UDI-DI Code
- B-08800069141018
- Reference
- R4101
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- SG Medical Inc.
Additional Description
ACROSIS COVID-19 Ag (NPS) is an in vitro diagnostic rapid test for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human nasopharyngeal swab. This test is intended for use by medical professionals or trained operators who are proficient in performing tests. The product can be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulations. The test provides only preliminary test results. The test results cannot be used as the sole basis for treatment or other patient management decisions.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).