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Advanced Instruments GloCyte® Count Template Cartridge
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Advanced Instruments GloCyte® Count Template Cartridge FDA UDI
- Generic Name
- Haematological cell analyser IVD FDA UDI
- Device Name
- For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Count Template Cartridge has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. The Count Template Cartridge is a service tool used to check the performance of the GloCyte System. FDA UDI
- Model / Reference
- 111153 FDA UDI
- Description
- For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Count Template Cartridge has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. The Count Template Cartridge is a service tool used to check the performance of the GloCyte System. FDA UDI
Identifiers
- Catalog Number
- 111153 FDA UDI
- Primary DI / UDI-DI
- 00816068020245 FDA UDI
- 510(k) Number
- K152776 FDA UDI
- FDA Product Code
- GKL FDA UDI
- GMDN Term
- Haematological cell analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haematological cell analyser IVD
Advanced Instruments GloCyte® Count Template Cartridge by Advanced Instruments, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152776 also covers:
- Advanced Instruments GloCyte® Controls Kit — Advanced Instruments, LLC
- Advanced Instruments GloCyte® High Level Control Vial (Single) — Advanced Instruments, LLC
- Advanced Instruments GloCyte® Instrument Assembly — Advanced Instruments, LLC
- Advanced Instruments GloCyte® Low Level Control Vial (Single) — Advanced Instruments, LLC
- Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume — Advanced Instruments, LLC
- Advanced Instruments GloCyte® Pipette, 30µL Fixed Volume — Advanced Instruments, LLC
- Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit — Advanced Instruments, LLC
- Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays — Advanced Instruments, LLC
- Advanced Instruments GloCyte® Total Nucleated Cell Test Reagent Kit — Advanced Instruments, LLC
- Advanced Instruments GloCyte® Vacuum Preparation Station Assembly — Advanced Instruments, LLC
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 5a51416a-a189-440f-bda8-1af803cf038e 37 fields · synced Jun 8, 2026