FDA UDI
In Commercial Distribution
🇺🇸 United States
Leica ST5020 Config.2
DI: 04049188003140
·
Model: 14905020EU1
·
Leica Biosystems Nussloch GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Leica ST5020 Config.2
- Primary DI
- 04049188003140
- Version / Model
- 14905020EU1
- Catalog Number
- 14905020EU1
- Company Name
- Leica Biosystems Nussloch GmbH
- Labeler DUNS
- 315539452
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-16
- Public Version
- 1
- Public Version Date
- 2018-12-17
- Public Version Status
- New
- Public Device Record Key
- eeeb5fb5-1f7d-423d-888b-b94fbbb2aa58
Device Description
The Stainer Leica ST5020 is an automated stain-er for the preparation of histological and cyto-logical routine stainings. It is designed for use in pathology laboratories, and only for performing the following tasks: • Staining of thin sections of tissue specimens or of cytological samples, attached to micro-scope slides • The instrument may be operated only ac¬cording to the instructions contained in this manual.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 04049188003140 | GS1 |
Customer Contacts
- Phone
- +4962241430
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify |
Storage Conditions
- Type
- Special Storage Condition, Specify