International Medical Devices Database

Manufacturer Address
Nichols Institute Diagnostics, 1311 Calle Batido, San Clemente CA 92673-6316
Source
USFDA
10 Events

10 devices in the database

EPO Calibration Verifiers

Model / Serial
Kit lots# 63-502081, 63-502081A contain Calibration Verifiers 1, 2, and 3. Lot #30-500952 is specific to Calibration Verifier 2; Lot #30-500953 is specific to Calibration Verifier 3.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
CA, IN, WA
Product Description
Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512

Nichols Advantage ACTH Test System, catalog number 62-7004.

Model / Serial
Lot 62-500040 and 62-404296
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Hungary, Poland, Australia, Canada, Germany, Greece, Italy, Spain, Sweden
Product Description
Nichols Advantage ACTH Test System, catalog number 62-7004.

Nichols Advantage TSH - Third Generation

Model / Serial
Lots 62-400791 and 62-400796
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Germany, Greece and Spain
Product Description
Nichols Advantage TSH - Third Generation

Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045.

Model / Serial
Lot 62-402651
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Japan, Spain, Germany and Sweden
Product Description
Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045.

Bio-Intact PTH (1-84) Assay

Model / Serial
Lots 62-402598 and 62-402622
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and to Australia, Canada, Chile, France, Germany, Greece, Italy, japan, Spain, Sweden
Product Description
Bio-Intact PTH (1-84) Assay, || Catalog No. 62-7040

5 more

2 manufacturers with a similar name

Learn more about the data here

NICHOLS INSTITUTE DIAGNOSTICS

Manufacturer Address
SAN CLEMENTE
Source
HC

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

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.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)

Nichols Institute Diagnostics