FDA UDI
In Commercial Distribution
🇺🇸 United States
PREVI® COLOR POLY-L-LYSINE SLIDES SINGLE
DI: 03573026227753
·
Model: PREVI® COLOR POLY-L-LYSINE SLIDES SINGLE
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
72
Basic Information
- Brand Name
- PREVI® COLOR POLY-L-LYSINE SLIDES SINGLE
- Primary DI
- 03573026227753
- Version / Model
- PREVI® COLOR POLY-L-LYSINE SLIDES SINGLE
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 72
- Record Status
- Published
- Publish Date
- 2020-08-14
- Public Version
- 1
- Public Version Date
- 2020-08-24
- Public Version Status
- New
- Public Device Record Key
- d93ae376-9b42-4aad-aa36-adf79a45990a
Device Description
Pre-coated single slides with Poly-L-Lysine to be used to reduce cell loss during wet fixation and staining (to be used with single sample chambers)
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KPA | Slide stainer, automated | Pathology | 864.3800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15599 | Microscope slide stainer IVD | An automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 03573026615208 | GS1 | ||||
| Primary | 03573026227753 | GS1 |