Identity
- Trade Name
- Theophylline FDA UDI
- Generic Name
- Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- 4491025190 FDA UDI
Identifiers
- Catalog Number
- 4491025190 FDA UDI
- Primary DI / UDI-DI
- 04015630997787 FDA UDI
- 510(k) Number
- K951595 FDA UDI
- FDA Product Code
- LGS FDA UDI
- GMDN Term
- Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3880 FDA UDI
- Commercial Distribution
- 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
No
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
Category: Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Theophylline by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry.
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- Theophylline — Roche Diagnostics Corp. · Class II
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- Theophylline — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K951595 also covers:
- Abuscreen OnLine Barbiturates — Roche Diagnostics Corp.
- Aspartate Aminotransferase acc to IFCC with pyridoxal phosphate activation — Roche Diagnostics Corp.
- Aspartate Aminotransferase acc to IFCC with pyridoxal phosphate activation — Roche Diagnostics Corp.
- Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation — Roche Diagnostics Corp.
- Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation — Roche Diagnostics Corp.
- Benzodiazepines — Roche Diagnostics Corp.
- Cannabinoids II — Roche Diagnostics Corp.
- Carbamazepine — Roche Diagnostics Corp.
- Creatine KinaseMB — Roche Diagnostics Corp.
- Creatine KinaseMB — Roche Diagnostics Corp.
- Creatinine Jaff Gen2 — Roche Diagnostics Corp.
- Creatinine Jaffe Gen.2 — Roche Diagnostics Corp.
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI e189d2f2-c1ec-4c09-8940-cac2972992c6 35 fields · synced May 30, 2026