SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Address:GLYN RHONWY,LLANBERIS Wales,GB

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Filters

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, CORTISOL (CGR) (2) RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE (CGJ) (2) RADIOIMMUNOASSAY, LUTEINIZING HORMONE (CEP) (2) RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) (CFT) (2) RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) (JKC) (1) RADIOIMMUNOASSAY, PROGESTERONE (JLS) (1)

Premarket Exempt

No Yes

Clear

IMMULITE 2000 Cortisol Kit Domestic 200T - 00630414167404 Catalog Number : L2KCO2(D)

Device Description : IMMULITE 2000 Cortisol Kit Domestic 200T

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : CGR

Prescription Use : No

Device Count : 1

IMMULITE 2000 Crotisol Kit Domestic 600T - 00630414167411 Catalog Number : L2KCO6(D)

Device Description : IMMULITE 2000 Crotisol Kit Domestic 600T

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : CGR

Prescription Use : No

Device Count : 1

IMMULITE 2000 DHEAS Kit Domestic 200T - 00630414167428 Catalog Number : L2KDS2(D)

Device Description : IMMULITE 2000 DHEAS Kit Domestic 200T

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : JKC

Prescription Use : No

Device Count : 1

IMMULITE 2000 FSH Kit Domestic 200T - 00630414167435 Catalog Number : L2KFS2(D)

Device Description : IMMULITE 2000 FSH Kit Domestic 200T

Device Class : 1

Duns Number: 296822794

Premarket Exempt : Yes

Product Code : CGJ

Prescription Use : No

Device Count : 1

IMMULITE 2000 FSH Kit Domestic 600T - 00630414167442 Catalog Number : L2KFS6(D)

Device Description : IMMULITE 2000 FSH Kit Domestic 600T

Device Class : 1

Duns Number: 296822794

Premarket Exempt : Yes

Product Code : CGJ

Prescription Use : No

Device Count : 1

IMMULITE 2000 LH Kit Domestic 200T - 00630414167459 Catalog Number : L2KLH2(D)

Device Description : IMMULITE 2000 LH Kit Domestic 200T

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : CEP

Prescription Use : No

Device Count : 1

IMMULITE 2000 LH Kt Domestic 600T - 00630414167480 Catalog Number : L2KLH6(D)

Device Description : IMMULITE 2000 LH Kt Domestic 600T

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : CEP

Prescription Use : No

Device Count : 1

IMMULITE 2000 Prolactin Kit Domestic 200T - 00630414167497 Catalog Number : L2KPR2(D)

Device Description : IMMULITE 2000 Prolactin Kit Domestic 200T

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : CFT

Prescription Use : No

Device Count : 1

IMMULITE 2000 Prolactin Kit Domestic 600T - 00630414167503 Catalog Number : L2KPR6(D)

Device Description : IMMULITE 2000 Prolactin Kit Domestic 600T

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : CFT

Prescription Use : No

Device Count : 1

IMMULITE 2000 Progesterone Kit Domestic 600T - 00630414167510 Catalog Number : L2KPW6(D)

Device Description : IMMULITE 2000 Progesterone Kit Domestic 600T

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : JLS

Prescription Use : No

Device Count : 1

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