Hitachi Chemical Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 16
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Hitachi Chemical Diagnostics, Inc. makes
The company manufactures test reagent cartridges for clinical analyzers, including glucose (GLU), blood urea nitrogen (BUN), creatinine (CRE), liver enzymes (ALT, AST), calcium (CA), total bilirubin, C-reactive protein (CRP), total protein and albumin (TP/ALB), and carbon dioxide (CO₂). It also produces allergen-specific IgE assay kits for diagnosing allergies, such as the 12-allergen bundle and latex-specific tests. Automated clinical instruments like the AP3600 are part of the portfolio, designed for laboratory use in measuring biochemical and immunological markers.
These products are regulated under FDA 510(k) clearance, with most falling under Class I and Class II device classifications. The company’s reagents and instruments are listed in the FDA’s 510(k) registry, reflecting their authorised status for clinical diagnostic use in the United States.
Catalogue
Search and filter all 16 devicesFDA recalls
FDA recall records list 1 recall initiated by Hitachi Chemical Diagnostics, Inc., initiated on 2012-12-21. By recorded status: 1 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 21 Dec 2012 Z-0793-2013 Class III Terminated There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low fill volume which could lead to a false negative results.
Frequently asked questions
How many devices does Hitachi Chemical Diagnostics, Inc. have in the registry?
The registry currently lists 16 devices for Hitachi Chemical Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hitachi Chemical Diagnostics, Inc.'s devices?
Among its 16 most recently registered devices, Hitachi Chemical Diagnostics, Inc. has devices listed in FDA 510(k) (16 devices).
What risk classes do Hitachi Chemical Diagnostics, Inc.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for Hitachi Chemical Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Hitachi Chemical Diagnostics, Inc.?
FDA recall records list 1 recall initiated by Hitachi Chemical Diagnostics, Inc., the most recent initiated on 21 Dec 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Hitachi Chemical Diagnostics, Inc. in the registry?
The most recently registered devices listed for Hitachi Chemical Diagnostics, Inc. include HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU), Allergen-Specific IgE Assay 12 Allergen Bundle, S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE and HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST.