Siemens Healthcare Diagnostics Inc.

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

Assay, genotyping, hepatitis c virus (OBF) (4) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (2) CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE (JQP) (1) ENZYMATIC, CARBON-DIOXIDE (KHS) (1) MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL (DDR) (1) SLIDE STAINER, AUTOMATED (KPA) (1)

Premarket Exempt

No Yes

Clear

ADVIA® Chemistry MYO Myoglobin Reagents - 00630414000190 Catalog Number : 4862455

Device Description : Myoglobin - ADVIA Chem. - RGT - 2x100 tests

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : DDR

Prescription Use : No

Device Count : 1

ADVIA Autoslide® Slide Maker Stainer - 00630414000220 Catalog Number : 085-A002-03

Device Description : ADVIA® Autoslide Slide Maker Stainer

Device Class : 1

Duns Number: 064608573

Premarket Exempt : No

Product Code : KPA

Prescription Use : No

Device Count : 1

VERSANT HCV 2.0 LiPA - 00630414000497 Catalog Number : 10719666

Device Description : VERSANT HCV Amplification 2.0 Kit (LiPA) 40 Test for HCV genotyping

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : OBF

Prescription Use : No

Device Count : 1

VERSANT HCV 2.0 LiPA - 00630414000503 Catalog Number : 10719667

Device Description : VERSANT HCV Amplification 2.0 Kit (LiPA) 100 Test for HCV genotyping

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : OBF

Prescription Use : No

Device Count : 1

VERSANT HCV Control 2.0 Kit (LiPA) - 00630414000510 Catalog Number : 10719668

Device Description : VERSANT HCV Control 2.0 Kit

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : OBF

Prescription Use : No

Device Count : 1

VERSANT - 00630414000534 Catalog Number : 10492006

Device Description : LiPAScan software

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : OBF

Prescription Use : No

Device Count : 1

ADVIA Chemistry CO2_c - 00630414000541 Catalog Number : 10720780

Device Description : ADVIA Chemistry CO2_c 20mL

Device Class :

Duns Number: 064608573

Premarket Exempt : No

Product Code : KHS

Prescription Use : No

Device Count : 4

Xprecia Stride™ Accessory Kit - 00630414001975 Catalog Number : 10714617

Device Description : Stride Device Manager Application software kit

Device Class : 1

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : JQP

Prescription Use : No

Device Count : 1

Atellica IM 1600 Analyzer - 00630414002026 Catalog Number : 11066000

Device Description : Atellica IM 1600 Analyzer

Device Class : 1

Duns Number: 064608573

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Atellica CH 930 Analyzer - 00630414002163 Catalog Number : 11067000

Device Description : Atellica CH 930 Analyzer

Device Class : 1

Duns Number: 064608573

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

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