Siemens Healthcare Diagnostics Inc.

Address:430 S Beiger St,Mishawaka,IN,46544,US

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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

Single (specified) analyte controls (assayed and unassayed) (JJX) (3) CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (2) Interleukin 6 (QLC) (2) ASSAY, ERYTHROPOIETIN (GGT) (1) NADH OXIDATION/NAD REDUCTION, ALT/SGPT (CKA) (1) Nadh oxidation/nad reduction, ast/sgot (CIT) (1)

Premarket Exempt

No Yes

Clear

ADVIA® Chemistry Enzyme 2 Calibrator - 00630414008974 Catalog Number : 10916058

Device Description : Enzyme 2 Calibrator - ADVIA Chemistry (ENZ 2 CAL)

Device Class : 2

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

ADVIA® Chemistry Enzyme 3 Calibrator - 00630414008981 Catalog Number : 10916059

Device Description : 6 vials of 1 calibrator level

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 1

Atellica CH ALTPLc - 00630414009056 Catalog Number : 11097638

Device Description : Alanine Aminotransferase Liquid (ALTPLc) Atellica CH - RGT 2080T

Device Class : 1

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : CKA

Prescription Use : No

Device Count : 1

Atellica CH ASTPLc - 00630414009063 Catalog Number : 11097639

Device Description : Aspartate Aminotransferase Liquid (ALTPLc) Atellica CH - RGT 2080T

Device Class : 2

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : CIT

Prescription Use : No

Device Count : 1

ADVIA Centaur Calcitonin MCM - 00630414010373 Catalog Number : 10995094

Device Description : Calcitonin (CALCT) ADVIA Centaur - Master Curve Material Kit 5 x 1 x 1.0mL

Device Class : 1

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

ADVIA Centaur EPO - 00630414010380 Catalog Number : 10995096

Device Description : Erythropoietin (EPO) - ADVIA Centaur - RGT 100T

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : GGT

Prescription Use : No

Device Count : 1

ADVIA Centaur EPO MCM - 00630414010397 Catalog Number : 10995098

Device Description : Erythropoietin (EPO) ADVIA Centaur - Master Curve Material Kit 5 x 1 x 1mL

Device Class : 1

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

ADVIA Centaur EPO Quality Control - 00630414010403 Catalog Number : 10995099

Device Description : Erythropoietin (EPO) QC Kit - ADVIA Centaur - CLT 3 x 3 x 7.0mL

Device Class : 1

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

ADVIA Centaur ® IL6 100T Kit - 00630414010434 Catalog Number : 10995080

Device Description : ADVIA Centaur ® IL-6 100T Kit

Device Class :

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : QLC

Prescription Use : No

Device Count : 1

ADVIA Centaur IL6 Control - 00630414010472 Catalog Number : 10995083

Device Class :

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : QLC

Prescription Use : No

Device Count : 1

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