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Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit FDA UDI
- Generic Name
- White blood cell count IVD, control FDA UDI
- Device Name
- Multilevel control that provides a means of measuring and verifying the performance of the GloCyte Cell counter for CSF for total nucleated and red blood cells. FDA UDI
- Model / Reference
- 111280 FDA UDI
- Description
- Multilevel control that provides a means of measuring and verifying the performance of the GloCyte Cell counter for CSF for total nucleated and red blood cells. FDA UDI
Identifiers
- Catalog Number
- 111280 FDA UDI
- Primary DI / UDI-DI
- 00816068020856 FDA UDI
- FDA Product Code
- JPK FDA UDI
- GMDN Term
- White blood cell count IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: White blood cell count IVD, controlRed blood cell count IVD, control
Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit by Advanced Instruments, LLC — Class II — FDA UDI — listed in FDA GUDID
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Advanced Instruments, LLC
Sources (1)
- FDA UDI 7c458f37-6697-4fac-811d-2e1550efde53 35 fields · synced Jun 8, 2026