Advanced Instruments GloCyte® Controls Kit

FDA UDI

Class II (US FDA UDI)

by Advanced Instruments, LLC

Identity

Trade Name: Advanced Instruments GloCyte® Controls Kit FDA UDI
Generic Name: Full blood count IVD, control FDA UDI
Device Name: For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Low and High Level Control Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains one 3mL vial of Low Level Control and one 3mL vial of High Level Control. FDA UDI
Model / Reference: 111013 FDA UDI
Description: For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Low and High Level Control Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains one 3mL vial of Low Level Control and one 3mL vial of High Level Control. FDA UDI

Identifiers

Catalog Number: 111013 FDA UDI
Primary DI / UDI-DI: 00816068020238 FDA UDI
510(k) Number: K152776 FDA UDI
FDA Product Code: JPK FDA UDI
GMDN Term: Full blood 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Full blood count IVD, control

Advanced Instruments GloCyte® Controls Kit 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:

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 ff51502a-61a8-4406-9c85-93e4f3cf3496 37 fields · synced Jun 8, 2026