RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mixture, Hematology Quality Control (JPK) (9) Control, Cell Counter, Normal And Abnormal (JCN) (1)

Premarket Exempt

No Yes

Clear

Research and Diagnostic Systems - 00815762021848 Catalog Number : CL034

Device Description : CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-4,6,7WBC CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-4,6,7WBC Levels 1-3,5-7PLT Levels 1,2,4,6,8,9Low Levels 1-6

Device Class : 2

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Research and Diagnostic Systems - 00815762021855 Catalog Number : CL035

Device Description : CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-6WBC Lev CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-6WBC Levels 1-3,5-7PLT Levels 1,2,4,5,7,8Low Levels 1-6

Device Class : 2

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Research and Diagnostic Systems - 00815762021862 Catalog Number : CL036

Device Class : 2

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Research and Diagnostic Systems - 00815762021923 Catalog Number : PTE5X

Device Description : Platelet-Trol Extended: 3 x 3mL (level 5)

Device Class :

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 3

Research and Diagnostic Systems - 00815762021930 Catalog Number : PTE4X

Device Description : Platelet-Trol Extended: 3 x 3mL (level 4)

Device Class :

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 3

Research and Diagnostic Systems - 00815762021947 Catalog Number : PTE6X

Device Description : Platelet-Trol Extended: 3 x 3mL (level 6)

Device Class :

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 3

Research and Diagnostic Systems - 00815762021954 Catalog Number : PTE3X

Device Description : Platelet-Trol Extended: 3 x 3mL (level 3)

Device Class :

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 3

Research and Diagnostic Systems - 00815762021961 Catalog Number : 72000

Device Description : CBC-7 2mL Dual Pack (6 Low, 6 Normal)

Device Class : 2

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

R & D Systems, Inc. CBC-PIX Hematology Control - 00815762021978 Catalog Number :

Device Description : CBC-PIX Hematology Control

Device Class : 2

Duns Number: 087248183

Premarket Exempt : Yes

Product Code : JCN

Prescription Use : Yes

Device Count : 1

Research and Diagnostic Systems - 10815762020091 Catalog Number : 3D501

Device Description : CBC-3D: 10 x 2mL Normal Pack

Device Class :

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 10

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