FDA UDI
In Commercial Distribution
🇺🇸 United States
Urine 1uL TS-SBA/MacCV TFS
DI: 09354646000087
·
Model: 5.1
·
Clever Culture Systems AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Urine 1uL TS-SBA/MacCV TFS
- Primary DI
- 09354646000087
- Version / Model
- 5.1
- Catalog Number
- AI-16054
- Company Name
- Clever Culture Systems AG
- Labeler DUNS
- 487097888
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-23
- Public Version
- 1
- Public Version Date
- 2020-03-31
- Public Version Status
- New
- Public Device Record Key
- 42cf12b1-ed9e-4f95-b643-df0765e305a6
Device Description
This Analysis Module is one of the family of AM’s designed to process incubated plates to assist with the detection of Urinary Tract Infections. See https://cleverculturesystems.com for further information.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PPU | Microbial Colony Image Assessment System | Microbiology | 866.2190 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64148 | Microbial culture plate imaging/analysis system IVD | An electrically-powered device intended to be used for the imaging and assessment of pre-inoculated, pre-incubated microbial culture plates. It typically consists of a sample handling/preparation unit, digital camera, optical reader, transfer unit and dedicated software for image capture, processing and/or analysis. It is not intended for incubation. The system may be a single self-contained unit or modular assembly. The device operates with minimal technician involvement and complete automation of all procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 19354646000084 | GS1 | Primary, bag | 1 | In Commercial Distribution | |
| Primary | 09354646000087 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183648 | 000 |