Roche Diagnostics Operations

FDA Filings

This page includes the latest FDA filings for Roche Diagnostics Operations. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
Roche Diagnostics Operations
Cobas HbA1c Test, Cobas B 101 System2017-07-28
ROCHE DIAGNOSTICS OPERATIONS
COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY2013-08-08
ROCHE DIAGNOSTICS OPERATIONS
TINA-QUANT ALBUMIN GEN.22012-05-14

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092975256Anvers,Belgium -> Norfolk, VirginiaDB9 - DRYLCE BOX 280 LIT HS CODE 3903110072 BOX
2020072253261Stadersand,Federal Republic of Germany -> Norfolk, VirginiaLABRATORY MATERIALS INVOICE NO. 9200265517 9200265518 HS CODE 90183900 90258040270 PCS
2020072140601Stadersand,Federal Republic of Germany -> Norfolk, VirginiaLABRATORY MATERIALS INVOICE NO. 9200265517 9200265518 HS CODE 90183900 90258040270 PCS
2020062346535Stadersand,Federal Republic of Germany -> Norfolk, VirginiaLABRATORY MATERIAL KIT WHOLE BLOOD COLLECTION TUBE IVD HS CODE 90183916 PCS
202006124216Stadersand,Federal Republic of Germany -> Norfolk, VirginiaLABORATORY MATERIAL KIT WHOLE BLOOD COLLECTIO N TUBE IVD HS CODE 90183910 PCS
2020051935563Stadersand,Federal Republic of Germany -> Norfolk, VirginiaLABORATORY MATERIAL KIT WHOLE BLOOD COLLECTIO N TUBE IVD HS CODE 90183910 PCS
2020030325926Stadersand,Federal Republic of Germany -> Norfolk, VirginiaLABORATORY MATERIAL KIT WHOLE BLOOD COLLECTIO N TUBE IVD HS CODE 90183910 PCS
2020022825187Stadersand,Federal Republic of Germany -> Norfolk, VirginiaLABORATORY MATERIAL KIT WHOLE BLOOD COLLECTIO N TUBE IVD HS CODE 90183910 PCS
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