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Research and Diagnostic Systems

FDA UDI

Class II (US FDA UDI)

by Research And Diagnostic Systems, Inc.

Identity

Trade Name
Research and Diagnostic Systems FDA UDI
Generic Name
T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI
Device Name
StatusFlowLo Control: 2 x 2.5mL FDA UDI
Model / Reference
FC237 FDA UDI
Description
StatusFlowLo Control: 2 x 2.5mL FDA UDI

Identifiers

Catalog Number
FC237 FDA UDI
Primary DI / UDI-DI
10815762021531 FDA UDI
FDA Product Code
GKZ FDA UDI
GMDN Term
T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5220 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

Dimensions & Sizes

Size
Total Volume — 5 Milliliter FDA UDI

Category: T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

Research and Diagnostic Systems by Research And Diagnostic Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Research And Diagnostic Systems, Inc.

Sources (1)

  • FDA UDI 523d3bd5-5482-42c2-a53b-840af1c7b48f 37 fields · synced Jun 8, 2026