FDA UDI
In Commercial Distribution
🇺🇸 United States
Accelerate PhenoTest® BC AST QC test
DI: 00862011000352
·
Model: 10107158
·
ACCELERATE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Accelerate PhenoTest® BC AST QC test
- Primary DI
- 00862011000352
- Version / Model
- 10107158
- Company Name
- ACCELERATE DIAGNOSTICS, INC.
- Labeler DUNS
- 186328670
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-15
- Public Version
- 2
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- 8eae1d16-c714-4693-80b8-1d3557d39b67
Device Description
The Accelerate PhenoTest® BC AST QC test is intended to serve as an external quality control to monitor the accuracy of the antimicrobial susceptibility test (AST) calls made by the Accelerate PhenoTest® BC kit. This quality control test is run in conjunction with the Accelerate PhenoTest® BC kit.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| PRH | Positive Blood Culture Identification And Ast Kit | Microbiology | 866.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61314 | Multiple-type bloodstream pathogen nucleic acid IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorganisms associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00862011000352 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN160032 | 000 |