FDA UDI
In Commercial Distribution
🇺🇸 United States
Advanced Instruments GloCyte® Automated Cell Counter System
DI: 00816068020139
·
Model: GloCyte
·
Advanced Instruments, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Advanced Instruments GloCyte® Automated Cell Counter System
- Primary DI
- 00816068020139
- Version / Model
- GloCyte
- Catalog Number
- GloCyte
- Company Name
- Advanced Instruments, LLC
- Labeler DUNS
- 125006353
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2026-02-06
- Public Version Status
- Update
- Public Device Record Key
- eaea5859-5765-450f-ace1-9ead6c8f5ed9
Device Description
For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients. Includes GloCyte instrument, computer, vacuum station, barcode reader, sample preparation tray, pipettes, and startup kit.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | Hematology | 864.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35476 | Haematological cell analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity, cytometry, and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. Some types may also include measurement of haemoglobin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816068020139 | GS1 |
Customer Contacts
- Phone
- +17813209000
- [email protected]