Atellica CH APO A1
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Atellica CH Apolipoprotein A-1 (APO A1) EUDAMEDAtellica CH APO A1 FDA UDI
- Generic Name
- Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_B_REAG_APO A1 EUDAMEDApolipoprotein A-1 (APO A1) Atellica CH - RGT 300T FDA UDI
- Model / Reference
- 11097625 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_B_REAG_APO A1 EUDAMED
- Description
- Apolipoprotein A-1 (APO A1) Atellica CH - RGT 300T FDA UDI
Identifiers
- Catalog Number
- 11097625 FDA UDI
- Primary DI / UDI-DI
- 00630414596242 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901656W3 EUDAMED
- 510(k) Number
- K992662 FDA UDI
- FDA Product Code
- MSJ FDA UDI
- EMDN Code
- W0102010401 APOLIPOPROTEIN A I EUDAMED
- GMDN Term
- Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1475 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
Atellica CH APO A1 by Siemens Healthcare Diagnostics — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry.
- Tinaquant Apolipoprotein A1 ver2 — Roche Diagnostics Corp. · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Alinity — Abbott · Class II
- APOLIPOPROTEIN A-I (APO A-I) — Randox Laboratories, Ltd. · Class I
- Human Apolipoprotein A-1 (Apo A-1) kit for use on SPAPLUS — The Binding Site Group · Class I
- APO A-I — Randox Laboratories, Ltd. · Class I
- APO A-I — Randox Laboratories, Ltd. · Class I
- N Antiserum to Human Apolipoprotein A-I — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
K992662 also covers:
- ADVIA® Chemistry APO A1 Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry APO B Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry IGA_2 Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry IGG_2 Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry IGM_2 Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry TRF Transferrin Reagents — Siemens Healthcare Diagnostics
- Atellica CH APO B — Siemens Healthcare Diagnostics
- Atellica CH IgA_2 — Siemens Healthcare Diagnostics
- Atellica CH IgG_2 — Siemens Healthcare Diagnostics
- Atellica CH IgM_2 — Siemens Healthcare Diagnostics
- Atellica CH Trf — Siemens Healthcare Diagnostics
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI 5a074e89-54c2-4274-b95b-7c5c917699ff 37 fields · synced Sep 17, 2026
- EUDAMED 6aade8a3-c434-48d0-9abb-6b67116f1afb 61 fields · synced Sep 17, 2026