SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

Address:40 Liberty Boulevard,Malvern,PA,19355,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) (4)

Premarket Exempt

Clear

IMMULITE®/IMMULITE® 1000 Systems SAMPLE CUPS - 00630414974187 Catalog Number : LSCP

Device Description : IMMULITE Sample Cups(1000/pack) - IMMULITE - CONS - 1000 Pieces

Device Class : 1

Duns Number: 186812384

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

IMMULITE® 1000 Systems1000 Sample Cup Caps - 00630414974194 Catalog Number : LSCC

Device Class : 1

Duns Number: 186812384

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

IMMULITE® 2000 XPi Sample Nesting Cups - 00630414982403 Catalog Number : 905288

Device Description : Test tube, non-sterile

Device Class : 1

Duns Number: 186812384

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

IMMULITE® 2000 Xpi Sample Nesting Cups - 00630414982410 Catalog Number : 905289

Device Description : Test tube, non-sterile

Device Class : 1

Duns Number: 186812384

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

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