Identity
- Trade Name
- SAS Legionella Test FDA UDI
- Generic Name
- Legionella pneumophila antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for the presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine. This test is intended to aid in the presumptive diagnosis of Legionnaires’ disease in conjunction with culture and other methods for patients with signs and symptoms of pneumonia. This test is for prescription use only. FDA UDI
- Model / Reference
- 044020 FDA UDI
- Description
- The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for the presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine. This test is intended to aid in the presumptive diagnosis of Legionnaires’ disease in conjunction with culture and other methods for patients with signs and symptoms of pneumonia. This test is for prescription use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00780311000165 FDA UDI
- GMDN Term
- Legionella pneumophila antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Legionella pneumophila antigen IVD, kit, rapid ICT, clinical
SAS Legionella Test by Sa Scientific, Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Legionella pneumophila antigen IVD, kit, rapid ICT, clinical.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Sa Scientific, Ltd
Sources (1)
- FDA UDI 458fa1cc-07f4-4ef4-8474-a6c7097f03da 33 fields · synced May 31, 2026