RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

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Filters

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) (10)

Premarket Exempt

No Yes

Clear

Research and Diagnostic Systems - 00815762020001 Catalog Number : 3R001

Device Description : R&D 3K Retic: 4 x 3mL (2 each Level 1,2)

Device Class : 2

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Research and Diagnostic Systems - 00815762020018 Catalog Number : 3R002

Device Description : R&D 3K Retic: 10 x 3mL (5 each Level 1,2)

Device Class : 2

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Research and Diagnostic Systems - 00815762020025 Catalog Number : 4R001

Device Description : R&D 4K Retic: 4 x 3mL (2 each Level 1,2)

Device Class : 2

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Research and Diagnostic Systems - 00815762020032 Catalog Number : 4R002

Device Description : R&D 4K Retic: 10 x 3mL (5 each Level 1,2)

Device Class : 2

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Research and Diagnostic Systems - 00815762020049 Catalog Number : RA003

Device Description : R&D Advia Retic Plus: 6 x 4mL (2 each Level 1, 2, 3)

Device Class : 2

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Research and Diagnostic Systems - 00815762020056 Catalog Number : BF001

Device Description : R&D Body Fluid: 2 x 2mL (1 each Level 1,2)

Device Class : 2

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Research and Diagnostic Systems - 00815762020063 Catalog Number : BF002

Device Description : R&D Body Fluid: 4 x 2mL (2 each Level 1,2)

Device Class : 2

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Research and Diagnostic Systems - 00815762020070 Catalog Number : BFI001

Device Description : R & D Body Fluid-I: 3 x 3mL (1 each Level 1,2,3)

Device Class : 2

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Research and Diagnostic Systems - 00815762020087 Catalog Number : BFI002

Device Description : R & D Body Fluid-I: 6 x 3mL (2 each Level 1,2,3)

Device Class : 2

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Research and Diagnostic Systems - 00815762020100 Catalog Number : 3D502

Device Description : CBC-3D: 10 x 2mL Dual Pack (5 Low, 5 High)

Device Class : 2

Duns Number: 087248183

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

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