Identity
- Trade Name
- Atellica IM Acid FDA UDI
- Generic Name
- Chemiluminescent immunoassay signal generation kit IVD FDA UDI
- Device Name
- Atellica IM Acid FDA UDI
- Model / Reference
- 11417929 FDA UDI
- Description
- Atellica IM Acid FDA UDI
Identifiers
- Catalog Number
- 11417929 FDA UDI
- Primary DI / UDI-DI
- 00630414613239 FDA UDI
- 510(k) Number
- K151792 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Chemiluminescent immunoassay signal generation kit 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chemiluminescent immunoassay signal generation kit IVD
Atellica IM Acid by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chemiluminescent immunoassay signal generation kit IVD.
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- IMMULITE®/IMMULITE® 1000 Systems SUBS — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Alinity — Abbott Ireland Diagnostics · Class I
- Atellica IM Acid / Base — Siemens Healthcare Diagnostics · Class I
Cleared under the same submission
K151792 also covers:
- Atellica IM 1300 Analyzer — Siemens Healthcare Diagnostics
- Atellica IM 1300 Analyzer — Siemens Healthcare Diagnostics
- Atellica IM 1600 Analyzer — Siemens Healthcare Diagnostics
- Atellica IM 1600 Analyzer — Siemens Healthcare Diagnostics
- Atellica IM Acid / Base — Siemens Healthcare Diagnostics
- Atellica IM Base — Siemens Healthcare Diagnostics
- Atellica IM Cleaner — Siemens Healthcare Diagnostics
- Atellica IM Wash — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 0aed75ab-58df-4e21-a784-a121cc7e1051 37 fields · synced May 31, 2026