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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
CD34 cell marker IVD, kit, enzyme immunohistochemistry FDA UDI
Device Name
StatusFlowPro: 2 x 1.5mL (High Level) FDA UDI
Model / Reference
FC236H FDA UDI
Description
StatusFlowPro: 2 x 1.5mL (High Level) FDA UDI

Identifiers

Catalog Number
FC236H FDA UDI
Primary DI / UDI-DI
10815762021562 FDA UDI
FDA Product Code
GKZ FDA UDI
GMDN Term
CD34 cell marker IVD, kit, enzyme immunohistochemistry 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 — 3 Milliliter FDA UDI

Category: CD34 cell marker IVD, kit, enzyme immunohistochemistry

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 CD34 cell marker IVD, kit, enzyme immunohistochemistry.

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 7f985299-34e5-46b7-ac57-f1532a239426 37 fields · synced May 30, 2026