Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
In vitro diagnostic medical devices
/
Reagents
/
Infectious diseases
/
Controls/standards/calibrators - (infect. immunology/nat)
/
Controls - infect. immunology
/
Multiconstituent controls - inf.imm.
Multiconstituent controls - inf.imm.
W0105080807
124 devices
Devices
A1 Series 2500
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
QC Sets and Panels: Helix Elite™
Microbiologics, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
Optitrol Red, 1x pos, 1mL
LGC Clinical Diagnostics, Inc.
·
,
US
Class B
CE/IVDR
Synthetic Positive Controls for Respiratory Pathogens
AusDiagnostics Pty Ltd
·
,
AU
IVD Annex II List B
CE/IVDD
ToRCH IgG/IgM Negative Control
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class C
CE/IVDR
Accurun 1 S8100 Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
QC Sets and Panels: Helix Elite™
Microbiologics, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
ToRCH IgG Positive Control
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class C
CE/IVDR
Accurun 1 Series 5100 positive control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Synthetic Positive Controls for CSF
AusDiagnostics Pty Ltd
·
,
AU
IVD Annex II List B
CE/IVDD
Optitrol HIV p24, 4x pos, 5mL
LGC Clinical Diagnostics, Inc.
·
,
US
Class B
CE/IVDR
Optitrol Orange
DiaMex GmbH
·
,
DE
Class B
CE/IVDR
TaqPath™ Menu | GeneProof™ Universal Internal Control
GeneProof a.s.
·
,
CZ
Class B
CE/IVDR
ToRCH IgG/IgM Negative Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
ToRCH IgM Positive Control
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class C
CE/IVDR
Optitrol Blue
LGC Clinical Diagnostics, Inc.
·
,
US
Class B
CE/IVDR
Optitrol HIV p24, 2x pos, 2.5mL
LGC Clinical Diagnostics, Inc.
·
,
US
Class B
CE/IVDR
Synthetic Positive Controls for Bacteria and Bacterial Resistance
AusDiagnostics Pty Ltd
·
,
AU
IVD General
CE/IVDD
SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +)
Randox Laboratories Limited
·
,
XI
Class B
CE/IVDR
GUDID
on market
ToRCH IgG Positive Control
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class C
CE/IVDR
Previous
Next