← Back to catalogue

Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit

FDA UDI

Class II (US FDA UDI)

by Advanced Instruments, LLC

Identity

Trade Name
Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit FDA UDI
Generic Name
Red cell antibody eluting IVD, reagent FDA UDI
Device Name
For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Red Blood Cell Reagent Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains three 1.8mL vials of Red Blood Cell (RBC) Reagent. FDA UDI
Model / Reference
111011 FDA UDI
Description
For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Red Blood Cell Reagent Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains three 1.8mL vials of Red Blood Cell (RBC) Reagent. FDA UDI

Identifiers

Catalog Number
111011 FDA UDI
Primary DI / UDI-DI
10816068020211 FDA UDI
510(k) Number
K152776 FDA UDI
FDA Product Code
GKL FDA UDI
GMDN Term
Red cell antibody eluting IVD, reagent 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

Yes

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

Yes

FDA UDI

Category: Red cell antibody eluting IVD, reagent

Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit by Advanced Instruments, LLC — Class II — FDA UDI — listed in FDA GUDID

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 6a273521-b0c5-4492-96ca-f30f451f1419 37 fields · synced Jun 8, 2026