FDA UDI
In Commercial Distribution
🇺🇸 United States
Sensititre GP Panel PLATE DRY CLI GRAM+ ID AUTO
DI: 00848838074363
·
Model: GPID
·
REMEL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sensititre GP Panel PLATE DRY CLI GRAM+ ID AUTO
- Primary DI
- 00848838074363
- Version / Model
- GPID
- Company Name
- REMEL, INC.
- Labeler DUNS
- 065769564
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-20
- Public Version
- 1
- Public Version Date
- 2023-06-28
- Public Version Status
- New
- Public Device Record Key
- 5283b48e-7ec1-443c-b89d-4076081476a6
Device Description
PLATE DRY CLI GRAM+ ID AUTO A semi-quantitative test intended for the automated identification of Gram positive bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
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
- Yes
- 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 |
|---|---|---|---|---|
| LQL | Gram Positive Identification Panel | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50419 | Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit | A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of aerobic gram positive bacteria that have been isolated by culture from a clinical specimen. Bacteria which may be identified typically belong to the genera Staphylococcus, Enterococcus, or may represent other gram positive cocci and gram positive bacilli genera. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848838074363 | GS1 |