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

Single (specified) analyte controls (assayed and unassayed) (JJX) (3) Drug mixture control materials (DIF) (2) CALIBRATOR, SECONDARY (JIT) (1) ANTISTREPTOLYSIN - TITER/STREPTOLYSIN O REAGENT (GTQ) (1) IMMUNOASSAY METHOD, TROPONIN SUBUNIT (MMI) (1) CALIBRATORS, DRUG MIXTURE (DKB) (1) CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (1)

Premarket Exempt

No Yes

Clear

VITROS - 10758750002306 Catalog Number : 6802218

Device Description : VITROS Chemistry Products ASO Reagent

Device Class : 1

Duns Number: 623873044

Premarket Exempt : Yes

Product Code : GTQ

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002504 Catalog Number : 6802301

Device Description : VITROS Immunodiagnostic Products Troponin I ES Reagent Pack

Device Class : 2

Duns Number: 068715424

Premarket Exempt : No

Product Code : MMI

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002535 Catalog Number : 6802304

Device Description : VITROS Chemistry Products Calibrator Kit 26

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : DKB

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002542 Catalog Number : 6802310

Device Description : VITROS Chemistry Products Calibrator Kit 99

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002559 Catalog Number : 6802311

Device Description : VITROS Chemistry Products AAT/HPT Performance Verifier I

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002566 Catalog Number : 6802312

Device Description : VITROS Chemistry Products AAT/HPT Performance Verifier II

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002573 Catalog Number : 6802313

Device Description : VITROS Chemistry Products AAT/HPT Performance Verifier III

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002597 Catalog Number : 6802323

Device Description : VITROS Chemistry Products Calibrator Kit 28

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002610 Catalog Number : 6802327

Device Description : VITROS Chemistry Products DAT Performance Verifier I

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002627 Catalog Number : 6802328

Device Description : VITROS Chemistry Products DAT Performance Verifier II

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

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