Identity
- Trade Name
- Atellica CH Tob FDA UDI
- Generic Name
- Tobramycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Tobramycin (Tob) Atellica CH - RGT 400T FDA UDI
- Model / Reference
- 11097517 FDA UDI
- Description
- Tobramycin (Tob) Atellica CH - RGT 400T FDA UDI
Identifiers
- Catalog Number
- 11097517 FDA UDI
- Primary DI / UDI-DI
- 00630414595962 FDA UDI
- 510(k) Number
- K962818 FDA UDI
- FDA Product Code
- LCR FDA UDI
- GMDN Term
- Tobramycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Tobramycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Atellica CH Tob by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tobramycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry.
Cleared under the same submission
K962818 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 244ca26e-25b4-4af0-9b49-52b2c18514a8 37 fields · synced May 30, 2026