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Sign in to claim this brandCAPITOL VIAL, INC.
US
Last updated May 30, 2026
What CAPITOL VIAL, INC. makes
Capitol Vial, Inc. manufactures drug-testing specimen collection kits designed for in vitro diagnostic (IVD) use, including oral fluid collection devices and evacuated blood collection tubes with K3EDTA anticoagulant. Their primary product, Oral-Eze, is used for oral fluid specimen collection, while they also supply Blood-Urine Specimen Kits for combined sample collection.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) database. Capitol Vial, Inc. 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 Capitol Vial, Inc. manufacture?
Capitol Vial, Inc. specializes in in vitro diagnostic (IVD) devices primarily used for drug-testing specimen collection. Their main products include oral fluid collection kits, such as the Oral-Eze, and evacuated blood collection tubes with K3EDTA anticoagulant. They also offer combined Blood-Urine Specimen Kits for multi-sample collection.
Where is Capitol Vial, Inc. based?
Capitol Vial, Inc. is headquartered in the United States. The company’s location is relevant for regulatory and compliance purposes, as it operates under U.S. medical device regulations.
Which regulatory registries or databases list Capitol Vial, Inc.’s devices?
Capitol Vial, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify their Class II medical devices, ensuring traceability and compliance with U.S. regulatory requirements.
How are Capitol Vial, Inc.’s devices classified under FDA regulations?
Capitol Vial, Inc.’s devices fall under Class II classification according to FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.
What is the primary purpose of Capitol Vial, Inc.’s Oral-Eze product line?
The Oral-Eze product line is designed specifically for collecting oral fluid (saliva) specimens, which are commonly used in drug testing and clinical diagnostics. Oral fluid collection is a non-invasive method that provides reliable results for detecting substances like drugs or biomarkers.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- 1-800-232-3342
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 151639481
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Blood - Urine Specimen Kit | SA94633 | FDA UDI | Class II | Unknown |
| Blood Specimen Convenience Kit | SA95201 | FDA UDI | Class II | Unknown |
| Blood Specimen Convenience Kit | SA94081 | FDA UDI | Class II | Unknown |
| Oral-Eze | 96505 | FDA UDI | Class II | Active |
| Blood - Urine Specimen Convenience Kit | SA93508 | FDA UDI | Class II | Unknown |
| Oral-Eze | 96405 | FDA UDI | Class II | Active |
| Blood - Urine Speciment Convenience Kit | SA93010 | FDA UDI | Class II | Unknown |
| Oral-Eze | 96500 | FDA UDI | Class II | Active |
| Blood Specimen Convenience Kit | SA95201 | FDA UDI | Class II | Unknown |
| Oral-Eze | SA96100 | FDA UDI | Class II | Active |
| Oral-Eze | SA96200 | FDA UDI | Class II | Active |
| Oral-Eze | 96401 | FDA UDI | Class II | Active |
| Oral-Eze | 96200 | FDA UDI | Class II | Active |
| Blood Specimen Convenience Kit | SA94721 | FDA UDI | Class II | Unknown |
| Blood - Urine Specimen Convenience Kit | SA93010 | FDA UDI | Class II | Unknown |
| Blood Specimen Convenience Kit | SA95204 | FDA UDI | Class II | Unknown |
| Blood - Urine Specimen Convenience Kit | SA93508 | FDA UDI | Class II | Unknown |
| Oral-Eze | 96501 | FDA UDI | Class II | Active |
| Blood Specimen Conveneience Kit | SA94721 | FDA UDI | Class II | Unknown |
| Oral-Eze | 96100 | FDA UDI | Class II | Active |
| Blood-Urine Specimen Kit | SA94633 | FDA UDI | Class II | Active |
| Blood Specimen Convenience Kit | SA95204 | FDA UDI | Class II | Unknown |
| Oral-Eze | 96400 | FDA UDI | Class II | Active |
| Oral-Eze | 95348 | FDA UDI | Class II | Active |
| Oral-Eze | 95376 | FDA UDI | Class II | Active |
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