FDA UDI
In Commercial Distribution
🇺🇸 United States
DensiCHEK™ plus
DI: 03573026222239
·
Model: 21250
·
BIOMERIEUX , INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DensiCHEK™ plus
- Primary DI
- 03573026222239
- Version / Model
- 21250
- Company Name
- BIOMERIEUX , INC.
- Labeler DUNS
- 086785110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-30
- Public Version
- 5
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- b65a4cca-04b7-4202-9843-549715fa88a9
Device Description
The DensiCHEK™ Plus instrument is designed for use with the VITEK®2 System to measure the optical density of a microorganism suspension.
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
- No
- 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 |
|---|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Microbiology | 866.1645 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36910 | Photometer, absorbance/transmission, automated | An electrically-powered, automated, stand-alone laboratory instrument intended to be used to determine the absorbance or transmission of light energy transmitted through a substance, typically a solution/liquid (e.g., saliva, urine), or gas. It is used for diagnostic and/or research purposes and detects scattered light intensity, absorption and/or fluorescence. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03573026222239 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083536 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius