← Back to catalogue

Advanced Instruments GloCyte® High Level Control Vial (Single)

FDA UDI

Class II (US FDA UDI)

by Advanced Instruments, LLC

Identity

Trade Name
Advanced Instruments GloCyte® High Level Control Vial (Single) FDA UDI
Generic Name
Full blood count IVD, control FDA UDI
Device Name
3 mL vial of High Level Control FDA UDI
Model / Reference
111113 FDA UDI
Description
3 mL vial of High Level Control FDA UDI

Identifiers

Primary DI / UDI-DI
00816068020191 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

No

FDA UDI

Single Use

Yes

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: Full blood count IVD, control

Advanced Instruments GloCyte® High Level Control Vial (Single) by Advanced Instruments, LLC — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Full blood count IVD, control.

Cleared under the same submission

K152776 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Advanced Instruments, LLC

Sources (1)

  • FDA UDI 1ebffdc0-5cbb-4846-9992-d67826f03a94 36 fields · synced Jun 8, 2026