FDA UDI
In Commercial Distribution
🇺🇸 United States
Cytopro® Rotor
DI: 03661540301179
·
Model: AC-160
·
ELITECHGROUP INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cytopro® Rotor
- Primary DI
- 03661540301179
- Version / Model
- AC-160
- 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
- a33f1391-947c-4f49-aa53-68ef11cf49d3
Device Description
The Cytopro Cytocentrifuge rotor is an in vitro diagnostic medical device for fixing biological cell suspensions on glass microscope slides for cytological examination. It is an accessory for use with any Elitech Group Aerospray Slide Stainer/Cytocentrifuge. This manual pertains only to the Series 2 stainer/cytocentrifuge models.
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 |
|---|---|---|---|---|
| IFB | Cytocentrifuge | Pathology | 864.3300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58386 | Centrifugal sample concentrator | A mains electricity (AC-powered) laboratory device designed to condense fluid clinical specimens (e.g., serum, urine, cerebrospinal fluid, ascites) using centrifugal rotation in order to harvest and preserve the particulate matter. Commonly known as a cyto-spin, it separates fluid from the solid particles, or cellular elements, of a specimen so they are more concentrated. It typically consists of a centrifuge with various rotor heads, microtitre plates, tubes, microscope slides, funnels and/or cups to which the sample is added, and absorptive material, filters, fluid collecting traps or a vacuum source utilized to separate and remove the liquid component. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661540301179 | GS1 |
Customer Contacts
- Phone
- 1-800-453-2725
- [email protected]