FDA UDI
In Commercial Distribution
🇺🇸 United States
Alethia™ Group A Streptococcus
DI: 00840733102264
·
Model: 480150
·
MERIDIAN BIOSCIENCE, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alethia™ Group A Streptococcus
- Primary DI
- 00840733102264
- Version / Model
- 480150
- Catalog Number
- 480150
- Company Name
- MERIDIAN BIOSCIENCE, INC.
- Labeler DUNS
- 092815364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-09
- Public Version
- 1
- Public Version Date
- 2019-02-11
- Public Version Status
- New
- Public Device Record Key
- 3ec8b297-a956-42d9-a208-8ebebcb508f6
Device Description
The Alethia™ Group A Streptococcus (Group A Strep) assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) in throat swab specimens. The Alethia™ Group A Strep assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. Results from the Alethia™ Group A Strep assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OOI | Real Time Nucleic Acid Amplification System | Clinical Chemistry | 862.2570 | 2 |
| OYZ | Group A Streptococcus Nucleic Acid Amplification Assay System | Microbiology | 866.3740 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51714 | Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840733102264 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122019 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius