Identity
- Trade Name
- N Antiserum to Human Apolipoprotein A-I FDA UDI
- Generic Name
- Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems FDA UDI
- Model / Reference
- 10446437 FDA UDI
- Description
- Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems FDA UDI
Identifiers
- Catalog Number
- OUED09 FDA UDI
- Primary DI / UDI-DI
- 00842768011252 FDA UDI
- 510(k) Number
- K860894 FDA UDI
- FDA Product Code
- CFN FDA UDI
- GMDN Term
- Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 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: Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
N Antiserum to Human Apolipoprotein A-I by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry.
- Atellica CH APO A1 — Siemens Healthcare Diagnostics · Class I
- 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
- ADVIA® Chemistry APO A1 Reagents — Siemens Healthcare Diagnostics · Class I
- APO A-I — Randox Laboratories, Ltd. · Class I
Cleared under the same submission
K860894 also covers:
- N Antiserum to Human Antithrombin III — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human Apolipoprotein A-I — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human Apolipoprotein B — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human Apolipoprotein B — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human Fibrinogen — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human Haptoglobin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human Haptoglobin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human Plasminogen — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human a1-acid Glycoprotein — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Antiserum to Human a1-acid Glycoprotein — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 Products Ltd
Sources (1)
- FDA UDI 1dd5b5e0-38f2-431c-9c32-bfd2caca9455 37 fields · synced May 30, 2026