Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08800044300065
- Basic UDI-DI Code
- B-08800044300065
- Reference
- QMdRASTN02, QMdRASTP02, QMdRASTN03, QMdRASTP03, QMdRASTN05
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- QuantaMatrix Inc.
Additional Description
The dRAST system constitutes a fully automated system for in vitro determination of antimicrobial susceptibility of commonly isolated Gram-positive or Gram-negative bacterial pathogens directly from a clinical blood culture specimen confirmed positive for Gram-positive or Gram-negative cocci by Gram stain. The dRAST system generates MIC-based antimicrobial susceptibility results and interpretive (S/I/R) results based on FDA or CLSI defined breakpoints. Results are intended to be used for prescribing appropriate antibiotics for patients with bacterial infections.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0104080108 | GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED |
| W0104080107 | GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED |
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