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, THYROID-STIMULATING HORMONE (JLW) (2) RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE (CFL) (2) SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (2) ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) (NHX) (1) Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) (LOM) (1) SYSTEM, TEST, THYROID AUTOANTIBODY (JZO) (1) RADIOIMMUNOASSAY, PROGESTERONE (JLS) (1)

Premarket Exempt

No Yes

Clear

IMMULITE 2000 Progesterone Kit Domestic 200T - 00630414167718 Catalog Number : L2KPW2(D)

Device Description : IMMULITE 2000 Progesterone Kit Domestic 200T

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : JLS

Prescription Use : No

Device Count : 1

IMMULITE 2000 Third Generation TSH - 00630414210834 Catalog Number : L2KTS2(D)

Device Description : TSH - IMMULITE - RGT - 200 Tests

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : JLW

Prescription Use : No

Device Count : 1

IMMULITE 2000 Third Generation TSH - 00630414210841 Catalog Number : L2KTS6(D)

Device Description : TSH - IMMULITE - RGT - 600 Tests

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : JLW

Prescription Use : No

Device Count : 1

IMMULITE® 2000 TSI - 00630414597188 Catalog Number : L2KSI2(D)

Device Description : IMMULITE(R) 2000 TSI Assay

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : JZO

Prescription Use : No

Device Count : 1

IMMULITE® 2000 Systems IGF-I - 00630414601236 Catalog Number : L2KIGF2

Device Description : Insulin-like growth factor I (IGF-I) 200 test kit

Device Class : 1

Duns Number: 296822794

Premarket Exempt : Yes

Product Code : CFL

Prescription Use : No

Device Count : 1

IMMULITE®/IMMULITE® 1000 Systems IGF-I - 00630414601243 Catalog Number : LKIGF1

Device Description : Insulin-like growth factor I (IGF-I) 100 test kit

Device Class : 1

Duns Number: 296822794

Premarket Exempt : Yes

Product Code : CFL

Prescription Use : No

Device Count : 1

IMMULITE® 3RD GEN. PSA CVM - 00630414601939 Catalog Number : L3PSCVM

Device Description : 3rd Generation PSA CVM - IMMULITE – CONS

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

IMMULITE® Systems PTS Calibration Verification Material PSA - 00630414601946 Catalog Number : LPTSCVM

Device Description : PSA CVM - IMMULITE – CONS

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

IMMULITE® 2000 Systems CCP Anti-CCP IgG - 00630414601991 Catalog Number : L2KPI2(D)

Device Description : CCP IgG Ab - IMMULITE - RGT - 200 Tests

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : NHX

Prescription Use : No

Device Count : 1

IMMULITE® 2000 Systems HBsAg Confirmatory Kit - 00630414947433 Catalog Number : L2KCH1(D)

Device Description : HBsAg Confirmatory Kit 100 Test

Device Class : 3

Duns Number: 296822794

Premarket Exempt : No

Product Code : LOM

Prescription Use : No

Device Count : 1

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