SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Address:GLYN RHONWY,LLANBERIS Wales,GB

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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

RADIOIMMUNOASSAY, ESTRADIOL (CHP) (3) SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (2) RADIOIMMUNOASSAY, C-PEPTIDES OF PROINSULIN (JKD) (1) ALBUMIN, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL (DFJ) (1) SYSTEM, TEST, BETA-2-MICROGLOBULIN IMMUNOLOGICAL (JZG) (1) RADIOIMMUNOASSAY, CALCITONIN (JKR) (1) CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL (NQD) (1)

Premarket Exempt

No Yes

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IMMULITE®/IMMULITE® 1000 Systems E2 Estradiol - 00630414947891 Catalog Number : LKE21(D)

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : CHP

Prescription Use : No

Device Count : 1

IMMULITE® 2000 Systems E2 Estradiol - 00630414947907 Catalog Number : L2KE22(D)

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : CHP

Prescription Use : No

Device Count : 1

IMMULITE® 2000 Systems E2 Estradiol - 00630414947914 Catalog Number : L2KE26(D)

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : CHP

Prescription Use : No

Device Count : 1

IMMULITE Systems Unconjugated Estriol (uE3) CVM - 00630414947921 Catalog Number : LUE3CVM(D)

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

IMMULITE® Systems BMG CONTROL Beta-2 Microglobulin - 00630414952956 Catalog Number : BMCM

Device Description : B2-MICROGLOBULIN - IMMULITE - CTL - 3x1mL

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : JZG

Prescription Use : No

Device Count : 1

IMMULITE® Systems CPE CONTROL C-Peptide - 00630414953007 Catalog Number : PECM

Device Description : C-Peptide - IMMULITE - CTL - 3x2mL

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : JKD

Prescription Use : No

Device Count : 1

IMMULITE® Systems ACT CONTROL ACTH - 00630414953090 Catalog Number : LACCM

Device Description : ACTH - IMMULITE - CTL - 2x2mL

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

IMMULITE® Systems ALB CONTROL Albumin - 00630414953106 Catalog Number : LHACM

Device Description : Albumin - IMMULITE - CTL - 2x2mL

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : DFJ

Prescription Use : No

Device Count : 1

IMMULITE® Systems CONTROL Calcitonin - 00630414953120 Catalog Number : LCLCM

Device Description : IMMULITE® Systems CONTROL Calcitonin

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : JKR

Prescription Use : No

Device Count : 1

IMMULITE® Systems CRP CONTROL C-Reactive Protein - 00630414953144 Catalog Number : LCRCM

Device Description : IMMULITE® Systems CRP CONTROL C-Reactive Protein

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : NQD

Prescription Use : No

Device Count : 1

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