Identity
- Trade Name
- Atellica CH CHK FDA UDI
- Generic Name
- Optical laboratory instrument performance standard calibrator/control IVD, single-use FDA UDI
- Device Name
- Check ReagentT Fluid (CHK) Atellica CH - CONS 4 X 47mL/4 X 47mL FDA UDI
- Model / Reference
- 11099311 FDA UDI
- Description
- Check ReagentT Fluid (CHK) Atellica CH - CONS 4 X 47mL/4 X 47mL FDA UDI
Identifiers
- Catalog Number
- 11099311 FDA UDI
- Primary DI / UDI-DI
- 00630414596556 FDA UDI
- 510(k) Number
- K151767 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Optical laboratory instrument performance standard calibrator/control IVD, single-use 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: Optical laboratory instrument performance standard calibrator/control IVD, single-use
Atellica CH CHK by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Optical laboratory instrument performance standard calibrator/control IVD, single-use.
- Neutral Density Densitometer Control for SPIFE 4000 — Helena Laboratories, Corp. · Class I
- RABS — Randox Laboratories, Ltd. · Class I
- SABS — Randox Laboratories, Ltd. · Class I
- Redi-Check Photometer QC — AWARENESS TECHNOLOGY, INCORPORATED · Class II
- AU — Beckman Coulter, Inc. · Class I
- DriDye 450 — AWARENESS TECHNOLOGY, INCORPORATED · Class I
- Device Qualification Test Kit EUROLabLiquidHandler — EUROIMMUN Medizinische Labordiagnostika AG · Class I
- DriDye 405 — AWARENESS TECHNOLOGY, INCORPORATED · Class I
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 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 976278c6-24bc-4d6b-a97c-44fd2680bbc2 37 fields · synced Jun 1, 2026