International Medical Devices Database

Manufacturer Address
Vital Diagnostics, Inc., 27 Wellington Rd, Lincoln RI 02865-4411
Manufacturer Parent Company (2017)
Ergon Capital Partners
Source
USFDA
5 Events

5 devices in the database

Device Recall ATAC Serum Control Kit

Model / Serial
Level 1, Lot Number 9137010 and Level 2, Lot Number 9138010.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide.
Product Description
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

Model / Serial
Level 1, Lot Number 9141010 and Level 2, Lot Number 9142010.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide.
Product Description
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

Model / Serial
All lots
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
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

Model / Serial
All lots
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
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

Model / Serial
All Lot Numbers
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Distributed Nationwide and Canada.
Product Description
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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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Vital Diagnostics, Inc.