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: Full blood count IVD, control FDA UDI
Device Name: CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-4,6,7 WBC Levels 1-6 PLT Levels 1,4,6,9-11 Low Levels 1-6 FDA UDI
Model / Reference: CL033 FDA UDI
Description: CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-4,6,7 WBC Levels 1-6 PLT Levels 1,4,6,9-11 Low Levels 1-6 FDA UDI

Identifiers

Catalog Number: CL033 FDA UDI
Primary DI / UDI-DI: 00815762021831 FDA UDI
510(k) Number: K942822 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

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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 72 Milliliter FDA UDI

Category: Full blood count IVD, control

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

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Cleared under the same submission

K942822 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

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Manufacturer

Manufacturer: Research And Diagnostic Systems, Inc.

Sources (1)

FDA UDI 7beed750-3a6e-4586-83c8-c98702064edc 38 fields · synced Jun 1, 2026