Leica Biosystems Nussloch GmbH

Address:HEIDELBERGER STR. 17-19,NUSSLOCH Baden-Wurttemberg,DE

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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

Slide stainer, automated (KPA) (9) DEVICE FOR SEALING MICROSECTIONS (KIM) (1)

Premarket Exempt

Yes

Clear

Insert Special Staining - 04049188060112 Catalog Number : 14047534525

Device Description : Leica Biosystems Accessory

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Rack Special Stainings - 04049188060129 Catalog Number : 14047534524

Device Description : Leica Biosystems Accessory

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Adapter Shandon - 04049188060181 Catalog Number : 14047534518

Device Description : Leica Biosystems Accessory

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Adapter - Medite 30 - 04049188060198 Catalog Number : 14047534517

Device Description : Leica Biosystems Accessory

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Adapter - Medite 20 - 04049188060204 Catalog Number : 14047534516

Device Description : Leica Biosystems Accessory

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Adapter - Sakura - 04049188060211 Catalog Number : 14047534515

Device Description : Leica Biosystems Accessory

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Lid, slotted - 04049188060396 Catalog Number : 14047534486

Device Description : Leica Biosystems Accessory

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Lid for 12 vessels - 04049188060990 Catalog Number : 14047533644

Device Description : Leica Biosystems Accessory

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Leica ST5020, Basic Instrument - 04049188061140 Catalog Number : 14047533623

Device Description : The Stainer Leica ST5020 is an automated stain-er for the preparation of histolo The Stainer Leica ST5020 is an automated stain-er for the preparation of histological and cyto-logical routine stainings. It is designed for use in pathology laboratories, and only for performing the following tasks: • Staining of thin sections of tissue specimens or of cytological samples, attached to micro-scope slides • The instrument may be operated only ac¬cording to the instructions contained in this manual.

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Slide rack 20, type Sakura, plastic - 04049188061355 Catalog Number : 14047433463

Device Description : Leica Biosystems Accessory

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : KIM

Prescription Use : No

Device Count : 1

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