DIAGAST

Address:Parc Eurasante,LOOS Hauts-de-France,FR

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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

Kit, Quality Control For Blood Banking Reagents (KSF) (1)

Premarket Exempt

No Yes

Clear

Beckman Coulter® PK® Systems Anti-B (9621A8) - 23661562173024 Catalog Number : 17302

Device Description : Blood Grouping Reagent Anti-B (Murine Monoclonal) formulated for Automated Syste Blood Grouping Reagent Anti-B (Murine Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 10

Beckman Coulter® PK® Systems Anti-AB (2521B8+16243G2+16247E10+7821D9) - 23661562173031 Catalog Number : 17303

Device Description : Blood Grouping Reagent Anti-A,B (Murine Monoclonal) formulated for Automated Sys Blood Grouping Reagent Anti-A,B (Murine Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 10

Beckman Coulter® PK® Systems Anti-D (P3X61+P3X21223B10+P3X290+P3X35) - 23661562173048 Catalog Number : 17304

Device Description : Blood Grouping Reagent Anti-D (Monoclonal Blend) formulated for Automated System Blood Grouping Reagent Anti-D (Monoclonal Blend) formulated for Automated Systems, Beckman Coulter® PK® Systems

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 10

Beckman Coulter® PK® Systems Anti-D (PK1) (P3X61) - 23661562173055 Catalog Number : 17305

Device Description : Blood Grouping Reagent Anti-D (Monoclonal-IgM) formulated for Automated Systems, Blood Grouping Reagent Anti-D (Monoclonal-IgM) formulated for Automated Systems, Beckman Coulter® PK® Systems

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 10

Beckman Coulter® PK® Systems Anti-D (PK2) (HM10) - 23661562173062 Catalog Number : 17306

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 10

Beckman Coulter® PK® Systems Anti-E (906) - 23661562173079 Catalog Number : 17307

Device Description : Blood Grouping Reagent Anti-E (Monoclonal) formulated for Automated Systems, Bec Blood Grouping Reagent Anti-E (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Beckman Coulter® PK® Systems Anti-C (P3X25531G8+MS24) - 23661562173093 Catalog Number : 17309

Device Description : Blood Grouping Reagent Anti-C (Monoclonal) formulated for Automated Systems, Bec Blood Grouping Reagent Anti-C (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Beckman Coulter® PK® Systems Anti-c (951) - 23661562173147 Catalog Number : 17314

Device Description : Blood Grouping Reagent Anti-c (Monoclonal) formulated for Automated Systems, Bec Blood Grouping Reagent Anti-c (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Beckman Coulter® PK® Systems Anti-K (MS56) - 23661562173154 Catalog Number : 17315

Device Description : Blood Grouping Reagent Anti-K (Monoclonal) formulated for Automated Systems, Bec Blood Grouping Reagent Anti-K (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Beckman Coulter® PK® Systems Control - 23661562173178 Catalog Number : 17317

Device Description : Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulte Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter® PK® System

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 10

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