FDA UDI
In Commercial Distribution
🇺🇸 United States
Aerospray Hematology Stat Slide Stainer/Cytocentrifuge
DI: 03661540303937
·
Model: Model 7122
·
ELITECHGROUP INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Aerospray Hematology Stat Slide Stainer/Cytocentrifuge
- Primary DI
- 03661540303937
- Version / Model
- Model 7122
- Company Name
- ELITECHGROUP INC.
- Labeler DUNS
- 052423787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2021-02-22
- Public Version Status
- Update
- Public Device Record Key
- 611cc175-fa5a-42c8-9e75-baef6fa9ccae
Device Description
The Aerospray Hematology Stat Slide Stainer/Cytocentrifuge (Model 7122) is intended for use by medical professionals to stain specimens that may include blood and other body fluids, as a step of standard laboratory practice in diagnosing disease in humans. Addition of the Cytopro rotor allows preparation of slides by cytocentrifugation before staining.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| 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 | 03661540303937 | GS1 |
Customer Contacts
- Phone
- +1 (800) 435 2725
- [email protected]