SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

Address:810 INNOVATION DR.,KNOXVILLE,TN,37932,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

ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (10)

Premarket Exempt

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VersaCell® X3 - 00630414595177 Catalog Number : 10793839

Device Description : VERSACELL X3 Instrument

Device Class : 1

Duns Number: 186812384

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

IMMULITE® 2000 XPi Immunoassay System - 00630414945422 Catalog Number : 030002-33

Device Description : IMMULITE® 2000 XPi Instrument

Device Class : 1

Duns Number: 186812384

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

IMMULITE® 1000 Immunoassay System - 00630414947440 Catalog Number : 030006-03

Device Description : IMMULITE® 1000 Instrument, 110 VOLT

Device Class : 1

Duns Number: 186812384

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

IMMULITE® 2000 Systems Reaction Tubes - 00630414954547 Catalog Number : LRXT

Device Description : Gear Driven Reaction Tubes 1000 - IMMULITE - CONS - 1000 Pieces

Device Class : 1

Duns Number: 186812384

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

IMMULITE® 2000 Systems Allergen Tube Caps - 00630414965734 Catalog Number : L2ATC

Device Description : IMMULITE® 2000 Systems Allergen Tube Cap

Device Class : 1

Duns Number: 186812384

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

IMMULITE® 2000 Systems Allergen Tubes - 00630414965741 Catalog Number : L2ATS2

Device Description : Allergen Tube Septa

Device Class : 1

Duns Number: 186812384

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

IMMULITE®2000 Systems Diluent Tube Caps - 00630414972923 Catalog Number : L2ZC

Device Class : 1

Duns Number: 186812384

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

IMMULITE® 2000 Systems Diluent Tubes - 00630414973159 Catalog Number : L2ZT

Device Class : 1

Duns Number: 186812384

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

IMMULITE® 2000 Systems Microsampling Tubes - 00630414973937 Catalog Number : LMST

Device Description : Microsampling Tubes - IMMULITE - CONS - 1000 Pieces

Device Class : 1

Duns Number: 186812384

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

IMMULITE® 2000 Systems Microsampling Tube Caps - 00630414974064 Catalog Number : LSMC

Device Class : 1

Duns Number: 186812384

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

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