FDA UDI
In Commercial Distribution
🇺🇸 United States
30-slide vented carousel for Aerospray®
DI: 03661540300028
·
Model: AC-189
·
ELITECHGROUP INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 30-slide vented carousel for Aerospray®
- Primary DI
- 03661540300028
- Version / Model
- AC-189
- Company Name
- ELITECHGROUP INC.
- Labeler DUNS
- 052423787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-19
- Public Version
- 1
- Public Version Date
- 2021-03-01
- Public Version Status
- New
- Public Device Record Key
- fc847fb6-116c-4b1e-9976-bbf942f1b8d4
Device Description
A 30-slide vented carousel to be used with Aerospray® stainer/cytocentrifuges to facilitate the staining of biological samples.
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
- 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 | 03661540300028 | GS1 |
Customer Contacts
- Phone
- 1-800-453-2725
- [email protected]