FDA UDI
In Commercial Distribution
🇺🇸 United States
Leica ST4020 China
DI: 04049188203908
·
Model: 000000014050954854
·
Leica Biosystems Nussloch GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Leica ST4020 China
- Primary DI
- 04049188203908
- Version / Model
- 000000014050954854
- Catalog Number
- 14050954854
- Company Name
- Leica Biosystems Nussloch GmbH
- Labeler DUNS
- 315539452
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-04
- Public Version
- 1
- Public Version Date
- 2019-01-04
- Public Version Status
- New
- Public Device Record Key
- c113f26a-3bb8-44bc-a5bc-5a4ee3724ee6
Device Description
The Leica Small Linear Stainer ST4020 is used for the automated preparation of routine histo¬logical and cytological stains. It is i ntended for use in pathology laboratories to assist with the following tasks: • Staining thin tissue sections or cytological specimens on slides. Frozen sections can also be stained. • The instrument may be operated only ccording 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 | 04049188203908 | GS1 |
Customer Contacts
- Phone
- +4962241430
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify |
Storage Conditions
- Type
- Special Storage Condition, Specify