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Atellica A-LYTE™ Integrated Multisensor Na+ / K+ / Cl-
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Atellica A-LYTE™ Integrated Multisensor Na+ / K+ / Cl- FDA UDI
- Generic Name
- Multiple electrolyte IVD, kit, ion-selective electrode (ISE) FDA UDI
- Device Name
- A-LYTE™ IMT (Na K Cl) Atellica CH - RGT FDA UDI
- Model / Reference
- 11099315 FDA UDI
- Description
- A-LYTE™ IMT (Na K Cl) Atellica CH - RGT FDA UDI
Identifiers
- Catalog Number
- 11099315 FDA UDI
- Primary DI / UDI-DI
- 00630414596518 FDA UDI
- FDA Product Code
- CEM FDA UDICGZ FDA UDIJGS FDA UDI
- GMDN Term
- Multiple electrolyte IVD, kit, ion-selective electrode (ISE) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1600 FDA UDI862.1170 FDA UDI862.1665 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: Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Atellica A-LYTE™ Integrated Multisensor Na+ / K+ / Cl- by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Multiple electrolyte IVD, kit, ion-selective electrode (ISE).
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- CLC720 Chemistry Analyzer w/ISE — Carolina Liquid Chemistries Corp. · Class I
- CLC1600 Chemistry Analyzer with ISE Module — Carolina Liquid Chemistries Corp. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- SelectaLyte (Chloride Electrode) — AWARENESS TECHNOLOGY, INCORPORATED · Class II
- SelectaLyte (Sodium Electrode) — AWARENESS TECHNOLOGY, INCORPORATED · Class II
- CLC800 Chemistry Analyzer with ISE Module — Carolina Liquid Chemistries Corp. · Class II
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 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
- Atellica CH EMPTY2 — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI c8922976-58cf-4901-9fde-b020e57cbc8d 37 fields · synced May 30, 2026