Identity
- Trade Name
- Atellica A-LYTE IMT Standard A FDA UDI
- Generic Name
- Multiple electrolyte IVD, calibrator FDA UDI
- Device Name
- IMT Standard A - Atellica CH - CONS 2 x 1.5L FDA UDI
- Model / Reference
- 11099304 FDA UDI
- Description
- IMT Standard A - Atellica CH - CONS 2 x 1.5L FDA UDI
Identifiers
- Catalog Number
- 11099304 FDA UDI
- Primary DI / UDI-DI
- 00630414595740 FDA UDI
- 510(k) Number
- K151767 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Multiple electrolyte IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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, calibrator
Atellica A-LYTE IMT Standard A by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple electrolyte IVD, calibrator.
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- Calibrator 2 — TOKYO BOEKI MEDISYS INC. · Class II
- Alfa Wassermann — Alfa Wassermann, Inc.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class II
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class II
Cleared under the same submission
K151767 also covers:
- Atellica A-LYTE IMT Diluent — 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
- 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 1b154140-5a0f-4340-9bb7-2f138e5e4300 37 fields · synced Jun 8, 2026