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Sign in to claim this brandPantex
US
Last updated May 24, 2026
What Pantex makes
Pantex manufactures enzyme immunoassay (EIA) kits for in vitro diagnostics (IVD), including tests for total cortisol, total testosterone, estradiol (oestradiol), and progesterone. The company also produces saliva collection mouthpieces designed for hormone analysis. These products are intended for laboratory use to measure hormone levels in biological samples.
The portfolio includes devices classified as Class I and Class II under regulatory frameworks, with authorisations listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. 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 Pantex manufacture?
Pantex specializes in in vitro diagnostics (IVD) products, primarily enzyme immunoassay (EIA) kits. These include tests for measuring total cortisol, total testosterone, estradiol (oestradiol), and progesterone levels in biological samples. The company also produces saliva collection mouthpieces, which are designed specifically for hormone analysis. These devices are intended for laboratory use to support hormone measurement.
Where is Pantex based, and what regulatory frameworks apply to its devices?
Pantex is based in the United States. Its devices fall under FDA regulatory oversight, with some classified as Class I and others as Class II. These classifications determine the level of regulatory scrutiny required for authorisation. The company’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases, which track their regulatory status and compliance.
Which registries or databases list Pantex’s medical devices?
Pantex’s devices are included in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The 510(k) database tracks premarket submissions for devices deemed substantially equivalent to existing authorised products, while the UDI system ensures traceability and identification of medical devices through unique codes. These registries help users verify the regulatory status of specific devices.
How are Pantex’s devices classified under regulatory standards?
Pantex’s devices are classified under the FDA’s medical device classification system as either Class I or Class II. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential harm, and the level of regulation needed to mitigate risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- pantexba.com
- —
- —
- [email protected]
- Phone
- 1-310-828-7423
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 072296809
Catalogue (48)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pantex P637SP | P637SP | FDA UDI | N/A | Active |
| Pantex P637SP | P637SP | FDA UDI | N/A | Active |
| Pantex P631SC | P631SC | FDA UDI | Class II | Active |
| Pantex P637SP | P637SP | FDA UDI | N/A | Active |
| Pantex P674SE | P674SE | FDA UDI | N/A | Active |
| Pantex P635ST | P635ST | FDA UDI | Class I | Active |
| Pantex | N/A | FDA UDI | Class I | Unknown |
| Pantex P637SP | P637SP | FDA UDI | N/A | Active |
| Pantex P635ST | P635ST | FDA UDI | Class I | Active |
| Pantex | N/A | FDA UDI | Class I | Active |
| Pantex P674SE | P674SE | FDA UDI | N/A | Active |
| Pantex P635ST | P635ST | FDA UDI | Class I | Active |
| Pantex P631SC | P631SC | FDA UDI | Class II | Active |
| Pantex P631SC | P631SC | FDA UDI | Class II | Active |
| Pantex P637SP | P637SP | FDA UDI | N/A | Active |
| Pantex | N/A | FDA UDI | Class II | Active |
| Pantex | N/A | FDA UDI | Class II | Unknown |
| Pantex P631SC | P631SC | FDA UDI | Class II | Active |
| Pantex P635ST | P635ST | FDA UDI | Class I | Active |
| Pantex P635ST | P635ST | FDA UDI | Class I | Active |
| Pantex P631SC | P631SC | FDA UDI | N/A | Active |
| Pantex Universal | 1 Universal | FDA UDI | Class I | Active |
| Pantex P631SC | P631SC | FDA UDI | Class II | Active |
| Pantex | N/A | FDA UDI | Class I | Active |
| Pantex | N/A | FDA UDI | Class II | Active |
| Pantex | N/A | FDA UDI | Class I | Unknown |
| Pantex P631SC | P631SC | FDA UDI | Class II | Active |
| Pantex P631SC | P631SC | FDA UDI | Class II | Active |
| Pantex P631SC | P631SC | FDA UDI | Class II | Active |
| Pantex P631SC | P631SC | FDA UDI | Class II | Active |
| Pantex | N/A | FDA UDI | Class I | Active |
| Pantex P631SC | P631SC | FDA UDI | Class II | Active |
| Pantex Universal | 1 Universal | FDA UDI | Class I | Active |
| Pantex P631SC | P631SC | FDA UDI | Class II | Active |
| Pantex P674SE | P674SE | FDA UDI | N/A | Active |
| Pantex P635ST | P635ST | FDA UDI | Class I | Active |
| Pantex | N/A | FDA UDI | Class I | Unknown |
| Pantex | N/A | FDA UDI | Class I | Active |
| Pantex P631SC | P631SC | FDA UDI | Class II | Active |
| Pantex P674SE | P674SE | FDA UDI | N/A | Active |
| Pantex P631SC | P631SC | FDA UDI | Class II | Active |
| Pantex P631SC | P631SC | FDA UDI | Class II | Active |
| Pantex P637SP | P637SP | FDA UDI | N/A | Active |
| Pantex Universal | 1 Universal | FDA UDI | Class II | Active |
| Pantex P674SE | P674SE | FDA UDI | N/A | Active |
| Pantex P674SE | P674SE | FDA UDI | N/A | Active |
| Pantex P674SE | P674SE | FDA UDI | N/A | Active |
| Neoscreen Elisa Hydroxyprogesterone | K940233 | FDA 510(k) | Class I | Active |
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