Siemens Healthcare Diagnostics Products GmbH

Address:76 EMIL-VON-BEHRING STRASSE,MARBURG Hesse,DE

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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

STAINS, HEMATOLOGY (KQC) (4) SYSTEM, AUTOMATED PLATELET AGGREGATION (JOZ) (3) TEST, SICKLE CELL (GHM) (2) CONTROL, HEMOGLOBIN (GGM) (1)

Premarket Exempt

No Yes

Clear

Diff-Quik™ Solution I - 00630414976310 Catalog Number : B4132-11A

Device Description : For differential staining in hematology that gives results similar to a Wright-G For differential staining in hematology that gives results similar to a Wright-Giemsa stain

Device Class : 1

Duns Number: 388240673

Premarket Exempt : Yes

Product Code : KQC

Prescription Use : No

Device Count : 1

Diff-Quik™ Solution II - 00630414976327 Catalog Number : B4132-12A

Device Description : For differential staining in hematology that gives results similar to a Wright-G For differential staining in hematology that gives results similar to a Wright-Giemsa stain

Device Class : 1

Duns Number: 388240673

Premarket Exempt : Yes

Product Code : KQC

Prescription Use : No

Device Count : 1

Dade® Sickle-Sol Test - 00630414976341 Catalog Number : B4585-1

Device Description : Qualitative Solubility for sickling hemoglobin

Device Class : 2

Duns Number: 388240673

Premarket Exempt : Yes

Product Code : GHM

Prescription Use : No

Device Count : 1

Dade® Sickle-Trol Hemoglobin Controls - 00630414976358 Catalog Number : B4585-10

Device Description : For testing for the presence of hemoglobin S in solubility tests and hemoglobing For testing for the presence of hemoglobin S in solubility tests and hemoglobing electrophoresis

Device Class : 2

Duns Number: 388240673

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : No

Device Count : 1

Dade® Sickle-Sol Test - 00630414976365 Catalog Number : B4585-5

Device Description : Qualitative Solubility for sickling hemoglobin

Device Class : 2

Duns Number: 388240673

Premarket Exempt : Yes

Product Code : GHM

Prescription Use : No

Device Count : 1

Diff-Quik™ Stain Set - 00630414992617 Catalog Number : B4132-1A

Device Description : For differential staining in hematology that gives results similar to a Wright-G For differential staining in hematology that gives results similar to a Wright-Giemsa stain

Device Class : 1

Duns Number: 388240673

Premarket Exempt : Yes

Product Code : KQC

Prescription Use : No

Device Count : 1

Diff-Quik™ Fixative - 00630414992624 Catalog Number : B4132-10A

Device Class : 1

Duns Number: 388240673

Premarket Exempt : Yes

Product Code : KQC

Prescription Use : No

Device Count : 1

Dade® PFA Collagen/EPI Test Cartridge - 00842768003660 Catalog Number : B4170-20A

Device Description : To aid in the detection of platelet dysfunction in citrated human whole blood

Device Class :

Duns Number: 388240673

Premarket Exempt : No

Product Code : JOZ

Prescription Use : No

Device Count : 20

Dade® PFA Collagen/ADP Test Cartridge - 00842768003684 Catalog Number : B4170-21A

Device Description : To aid in the detection of platelet dysfunction in citrated human whole blood

Device Class :

Duns Number: 388240673

Premarket Exempt : No

Product Code : JOZ

Prescription Use : No

Device Count : 20

Dade® PFA Trigger Solution - 00842768003691 Catalog Number : B4170-50

Device Description : To aid in the detection of platelet dysfunction in citrated human whole blood

Device Class :

Duns Number: 388240673

Premarket Exempt : No

Product Code : JOZ

Prescription Use : No

Device Count : 3

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