Identity
- Trade Name
- Atellica Direct Load Kit FDA UDI
- Generic Name
- Specimen processing instrument IVD FDA UDI
- Device Name
- Atellica DL PRIMARY KIT FDA UDI
- Model / Reference
- 11068009 FDA UDI
- Description
- Atellica DL PRIMARY KIT FDA UDI
Identifiers
- Catalog Number
- 11068009 FDA UDI
- Primary DI / UDI-DI
- 00630414002354 FDA UDI
- 510(k) Number
- K151767 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Specimen processing instrument IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Specimen processing instrument IVD
Atellica Direct Load Kit by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K151767 also covers:
- Atellica A-LYTE IMT Diluent — Siemens Healthcare Diagnostics
- Atellica A-LYTE IMT Standard A — Siemens Healthcare Diagnostics
- Atellica A-LYTE IMT Standard B + Salt Bridge — Siemens Healthcare Diagnostics
- Atellica A-LYTE™ Integrated Multisensor Na+ / K+ / Cl- — Siemens Healthcare Diagnostics
- Atellica CH 930 Analyzer — Siemens Healthcare Diagnostics
- Atellica CH AlbP Calibrator — Siemens Healthcare Diagnostics
- Atellica CH CHK — Siemens Healthcare Diagnostics
- Atellica CH Cleaner — Siemens Healthcare Diagnostics
- Atellica CH Conditioner — Siemens Healthcare Diagnostics
- Atellica CH Diluent — Siemens Healthcare Diagnostics
- Atellica CH EMPTY — Siemens Healthcare Diagnostics
- Atellica CH EMPTY1 — Siemens Healthcare Diagnostics
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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 6f77572a-8156-4ba2-ae5c-228b9a457fdf 36 fields · synced May 30, 2026