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

System, test, radioallergosorbent (rast) immunological (DHB) (7) SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (3)

Premarket Exempt

No Yes

Clear

IMMULITE 2000 rBet v 2 Specific Allergen - 00630414000138 Catalog Number : A127L2

Device Description : rBet v 2 Alleren

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : DHB

Prescription Use : No

Device Count : 1

IMMULITE 2000 Systems Anti-CCP IgG Calibration Verification Material - 00630414000206 Catalog Number : L2PICVM(D)

Device Description : IMMULITE® 2000 Systems CCP Calibration Verification Material Anti-CCP IgG

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

IMMULITE® GROWTH HORMONE CVM - 00630414000213 Catalog Number : LGRHCVM

Device Description : Growth Hormone CVM - IMMULITE - CONS

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

IMMULITE 2000 rMal d 1 Specific Allergen - 00630414006246 Catalog Number : A464L2

Device Description : rMal d 1 Allergen

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : DHB

Prescription Use : No

Device Count : 1

IMMULITE 2000 rPru av 3 Specific Allergen - 00630414006253 Catalog Number : A599L2

Device Description : rPru av 3 Allergen

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : DHB

Prescription Use : No

Device Count : 1

IMMULITE 2000 rPru av 4 Specific Allergen - 00630414006277 Catalog Number : A600L2

Device Description : rPru av 4 Allergen

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : DHB

Prescription Use : No

Device Count : 1

IMMULITE 2000 nPru p 3 Specific Allergen - 00630414006284 Catalog Number : A603L2

Device Description : nPru p 3 Allergen

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : DHB

Prescription Use : No

Device Count : 1

IMMULITE 2000 rMal d 4 Specific Allergen - 00630414006291 Catalog Number : A796L2

Device Description : rMal d 4 Allergen

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : DHB

Prescription Use : No

Device Count : 1

IMMULITE 2000 rPru av 1 Specific Allergen - 00630414006345 Catalog Number : A597L2

Device Description : rPru av 1 Allergen

Device Class : 2

Duns Number: 296822794

Premarket Exempt : No

Product Code : DHB

Prescription Use : No

Device Count : 1

IMMULITE® 2000 TSI CVM - 00630414006680 Catalog Number : L2SICVM

Device Description : IMMULITE(R) 2000 TSI CVM

Device Class : 1

Duns Number: 296822794

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

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