ORTHO-CLINICAL DIAGNOSTICS, INC.

Address:6005 Freeport Avenue, Suite 130,Memphis,TN,38141,US

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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

Drug mixture control materials (DIF) (3) ANTISTREPTOLYSIN - TITER/STREPTOLYSIN O REAGENT (GTQ) (2) Multi-analyte controls, all kinds (assayed) (JJY) (2) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (1) CALIBRATOR, PRIMARY (JIS) (1) CALIBRATOR, SECONDARY (JIT) (1)

Premarket Exempt

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VITROS - 10758750002634 Catalog Number : 6802329

Device Description : VITROS Chemistry Products DAT Performance Verifier III

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002641 Catalog Number : 6802330

Device Description : VITROS Chemistry Products DAT Performance Verifier IV

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002658 Catalog Number : 6802331

Device Description : VITROS Chemistry Products DAT Performance Verifier V

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002665 Catalog Number : 6802342

Device Description : VITROS Chemistry Products Calibrator Kit 27

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002672 Catalog Number : 6802344

Device Description : VITROS Chemistry Products Calibrator Kit 29

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002696 Catalog Number : 6802348

Device Description : VITROS Chemistry Products dTIBC Performance Verifier I

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002702 Catalog Number : 6802349

Device Description : VITROS Chemistry Products dTIBC Performance Verifier II

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002726 Catalog Number : 6802411

Device Description : VITROS Chemistry Products ASO/RF Performance Verifier I

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : GTQ

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002733 Catalog Number : 6802412

Device Description : VITROS Chemistry Products ASO/RF Performance Verifier II

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : GTQ

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002740 Catalog Number : 6802413

Device Description : VITROS 5600 Integrated System

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

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