Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat R.A.L. DIAGNOSTICS makes
R.A.L. Diagnostics manufactures Romanowsky stain kits and solutions for in vitro diagnostics, including fixative and staining reagents used in hematological examinations. Products include bulk solutions, pre-packaged kits, and compact EZ-kits designed for laboratory staining of blood smears and cytological samples.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does R.A.L. Diagnostics manufacture?
R.A.L. Diagnostics specializes in Romanowsky stain kits and solutions for in vitro diagnostics (IVD). These products are primarily used in hematology to prepare and stain blood smears and cytological samples. Examples include fixative solutions, staining reagents, and pre-packaged kits like the Ral Diff-Quik series, which streamline the staining process for laboratory analysis.
Where is R.A.L. Diagnostics based, and what is its primary focus?
R.A.L. Diagnostics is based in the United States. Its primary focus is developing and manufacturing Romanowsky stain kits and solutions tailored for in vitro diagnostics, particularly for hematological examinations. These tools are essential for preparing and visualizing blood and cytological samples in clinical and research settings.
Are R.A.L. Diagnostics’ devices listed in any regulatory registries, and if so, which ones?
Yes, R.A.L. Diagnostics’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I medical devices, including the company’s Romanowsky stain kits and solutions, which are used in diagnostic procedures.
How are R.A.L. Diagnostics’ devices classified by regulatory authorities?
R.A.L. Diagnostics’ devices fall under the FDA’s Class I classification. This classification is assigned to low-risk medical devices that pose minimal potential harm to users. Since these products are primarily used for staining and preparing samples in hematology, they are considered routine diagnostic tools with established safety profiles.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 264611820
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ral Diff-Quik Fixative Solution (1 x 2, 5L) | 03760177194533 | FDA UDI | Class I | Active |
| Ral Diff-Quik Solution I (1 x 2, 5L) | 03760177194540 | EUDAMEDFDA UDI | Class I | Active |
| Ral Diff-Quik Kit (3 x 500ml) | 03760177194526 | FDA UDI | Class I | Active |
| Ral Diff-Quik EZ-Kit (3 x 100ml) | 03760177194519 | FDA UDI | Class I | Active |
| Ral Diff-Quik Solution II (1 x 2, 5L) | 03760177194557 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.