Identity
- Trade Name
- THEO FDA UDI
- Generic Name
- Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- For the quantitative in vitro determination of Theophylline in human serum FDA UDI
- Model / Reference
- TD3412 FDA UDI
- Description
- For the quantitative in vitro determination of Theophylline in human serum FDA UDI
Identifiers
- Catalog Number
- TD3412 FDA UDI
- Primary DI / UDI-DI
- 05055273206432 FDA UDI
- 510(k) Number
- K011771 FDA UDI
- FDA Product Code
- KLS FDA UDI
- GMDN Term
- Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3880 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Theo by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI bf1b5e5a-9b27-4056-bdc7-9fcecbe29182 38 fields · synced Jun 8, 2026