Advanced Instruments GloCyte® Vacuum Preparation Station Assembly

FDA UDI

Class II (US FDA UDI)

by Advanced Instruments, LLC

Identity

Trade Name: Advanced Instruments GloCyte® Vacuum Preparation Station Assembly FDA UDI
Generic Name: Laboratory pump, vacuum FDA UDI
Device Name: For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Vacuum Station has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Accelerates the capturing of stained cells on the test cartridge. FDA UDI
Model / Reference: 111076 FDA UDI
Description: For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Vacuum Station has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Accelerates the capturing of stained cells on the test cartridge. FDA UDI

Identifiers

Catalog Number: 111076 FDA UDI
Primary DI / UDI-DI: 00816068020153 FDA UDI
510(k) Number: K152776 FDA UDI
FDA Product Code: GKL FDA UDI
GMDN Term: Laboratory pump, vacuum 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

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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Laboratory pump, vacuum

Advanced Instruments GloCyte® Vacuum Preparation Station Assembly by Advanced Instruments, LLC — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Laboratory pump, vacuum.

Patient Loading Utility System (PLUS) — LIFEPORT, LLC. · Class I
Patient Loading Utility System (PLUS) — LIFEPORT, LLC. · Class I
Utility Pedestal Assembly — LIFEPORT, LLC. · Class I
PLUS — LIFEPORT, LLC. · Class I
MedPak — LIFEPORT, LLC. · Class II
Patient Loading Utility System (PLUS) — LIFEPORT, LLC. · Class I
Patient Loading Utility System (PLUS) — LIFEPORT, LLC. · Class I
PLUS — LIFEPORT, LLC. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Advanced Instruments, LLC

Sources (1)

FDA UDI c96dbd9a-b490-45d3-b3d6-385e63c0cf9d 36 fields · synced Jun 8, 2026