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FAQ
Crédits
Manufacturers
Vital Diagnostics, Inc.
Adresse du fabricant
Vital Diagnostics, Inc., 27 Wellington Rd, Lincoln RI 02865-4411
Société-mère du fabricant (2017)
Ergon Capital Partners
Source
USFDA
5 Events
Rappel de Device Recall ATAC Serum Control Kit
Rappel de Device Recall Envoy 500 Serum Control Kit
Rappel de Device Recall Consult Diagnostics Eon Calcium Reagent For InVitro Diagnostic Use
Rappel de Device Recall Vital Diagnostics Envoy Calcium Reagent For InVitro Diagnostic Use
Rappel de Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or NonVacuum ESR Tubes
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5 dispositifs dans la base de données
Device Recall ATAC Serum Control Kit
Modèle / numéro de série
Level 1, Lot Number 9137010 and Level 2, Lot Number 9138010.
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide.
Description du dispositif
ATAC Serum Control Kit. || The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
Device Recall Envoy 500 Serum Control Kit
Modèle / numéro de série
Level 1, Lot Number 9141010 and Level 2, Lot Number 9142010.
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide.
Description du dispositif
Envoy 500 Serum Control Kit. || The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
Device Recall Consult Diagnostics Eon Calcium Reagent For InVitro Diagnostic Use
Modèle / numéro de série
All lots
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide Distribution
Description du dispositif
Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use || PN: 1429 || For the quantitative measurement of calcium in plasma and serum
Device Recall Vital Diagnostics Envoy Calcium Reagent For InVitro Diagnostic Use
Modèle / numéro de série
All lots
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide Distribution
Description du dispositif
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. || PN 55285 || For the quantitative measurement of calcium in plasma and serum
Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or NonVacuum ESR Tubes
Modèle / numéro de série
All Lot Numbers
Classification du dispositif
Hematology and Pathology Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Distributed Nationwide and Canada.
Description du dispositif
Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes. Single Use. Product Number: EX-I0552. Manufactured by Vital Diagnostics S.R.L., Italy. || Slider allows a larger label to be applied to the ESR tube.
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