27 results · 6ms · Sources: EU EUDAMED, US FDA

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IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·October 29, 2014

Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·October 29, 2014

ADVIA Centaur¿ HBc IgM

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN

FDA Enforcement
Class II ·Terminated·Arrow International Inc·February 19, 2020

IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

IMMULITE ¿ /IMMULITE ¿ 1000 CEA

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

IMMULITE ¿ /IMMULITE ¿ 1000 TG

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

FDA Enforcement
Class II ·Terminated·Biocompatibles U.K., Ltd.·October 19, 2016

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018