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

SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (2) ENZYME IMMUNOASSAY, DIPHENYLHYDANTOIN (DIP) (1) RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE (CFL) (1) RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) (JHR) (1) RADIOIMMUNOASSAY, PARATHYROID HORMONE (CEW) (1) Radioimmunoassay, thyroxine-binding globulin (CEE) (1) SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN (DHA) (1) COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE (JMM) (1) System,test,thyroglobulin (MSW) (1)

Premarket Exempt

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IMMULITE® Systems GAS CONTROL Gastrin - 00630414953199 Catalog Number : LGACM

Device Description : Gastrin - IMMULITE - CTL - 2x2mL

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : MSW

Prescription Use : No

Device Count : 1

IMMULITE® Systems HCG CONTROL HCG - 00630414953205 Catalog Number : LCGCM

Device Description : HCG - IMMULITE - CTL - 2x2mL

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 1

IMMULITE® Systems IG1 CONTROL IGF-1 - 00630414953212 Catalog Number : LGCOCM

Device Description : IGF - IMMULITE - CTL - 2x4mL

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : CFL

Prescription Use : No

Device Count : 1

IMMULITE® Systems PTH CONTROL Intact PTH - 00630414953236 Catalog Number : LPHCM

Device Description : PTH - IMMULITE - CTL - 6x2mL

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : CEW

Prescription Use : No

Device Count : 1

IMMULITE® Systems PDP CONTROL Pyrilinks-D - 00630414953281 Catalog Number : LPDCM

Device Description : Pyrilinks-D - IMMULITE - CTL - 2x2mL

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : JMM

Prescription Use : No

Device Count : 1

IMMULITE® Systems TBG CONTROL - 00630414953298 Catalog Number : LTBCM

Device Description : TBG - IMMULITE - CTL - 2x2.0mL

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : CEE

Prescription Use : No

Device Count : 1

IMMULITE® Systems TSH CONTROL Third Generation TSH - 00630414953311 Catalog Number : LTGCM

Device Description : TSH 3rd Gen - IMMULITE - CONS - 2x2.0mL

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

IMMULITE® Systems TAD CONTROL Thyroid Autoantibody - 00630414953335 Catalog Number : LAACM

Device Description : Thyroid Autoab - IMMULITE - CTL - 2x5mL

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

IMMULITE® Systems SDC CONTROL Serum Drug Control Module - 00630414953410 Catalog Number : SDCM

Device Description : Serum Drug - IMMULITE - CTL - 2x5mL

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : DIP

Prescription Use : No

Device Count : 1

IMMULITE® Systems TIE CONTROL Total IgE - 00630414953458 Catalog Number : IECM

Device Description : IgE total - IMMULITE - CTL - 2x2mL

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : JHR

Prescription Use : No

Device Count : 1

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