FDA UDI
In Commercial Distribution
🇺🇸 United States
Aerospray Cytology Slide Stainer/Cytocentrifuge
DI: 03661540304668
·
Model: 7522
·
ELITECHGROUP INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Aerospray Cytology Slide Stainer/Cytocentrifuge
- Primary DI
- 03661540304668
- Version / Model
- 7522
- Catalog Number
- Model 7522
- Company Name
- ELITECHGROUP INC.
- Labeler DUNS
- 052423787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-30
- Public Version
- 1
- Public Version Date
- 2021-04-07
- Public Version Status
- New
- Public Device Record Key
- bfe9ad93-543b-4ae9-81ff-1b91b0d791aa
Device Description
The Aerospray® Cytology Slide Stainer/Cytocentrifuge Model 7522 is intended for use by laboratory professionals to stain cytology specimens using the Papanicolaou staining method with ELITechGroup Papanicolaou stains only. The optional 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 | 03661540304668 | GS1 |
Customer Contacts
- Phone
- (800) 435 2725
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius