Identity
- Trade Name
- IMMULITE® Systems ALB CONTROL Albumin FDA UDI
- Generic Name
- Albumin IVD, control FDA UDI
- Device Name
- Albumin - IMMULITE - CTL - 2x2mL FDA UDI
- Model / Reference
- 10385388 FDA UDI
- Description
- Albumin - IMMULITE - CTL - 2x2mL FDA UDI
Identifiers
- Catalog Number
- LHACM FDA UDI
- Primary DI / UDI-DI
- 00630414953106 FDA UDI
- 510(k) Number
- K022603 FDA UDI
- FDA Product Code
- DFJ FDA UDI
- GMDN Term
- Albumin IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Albumin IVD, control
IMMULITE® Systems ALB CONTROL Albumin by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Albumin IVD, control.
- Eurotrol AlbuTrol — Eurotrol B.V. · Class I
- ABX PENTRA MICRO ALB CONTROL L/H — Horiba Abx · Class I
- Albumin control slides — BIO SB, INC. · Class I
- Albumin Control Slides — BIO SB, INC. · Class I
- Optilite® Low Level Albumin Control Pack — The Binding Site Group · Class I
- Eurotrol AlbuTrol — Eurotrol B.V. · Class I
- Autokit Micro Albumin Control Set — FUJIFILM WAKO PURE CHEMICAL CORPORATION · Class I
- Diazyme — Diazyme Laboratories, Inc.
Cleared under the same submission
K022603 also covers:
- IMMULITE® 2000 Systems ALB Albumin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems INS Insulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems INS Insulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems INS Insulin Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® INS Control Insulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE® 1000 Systems ALB Albumin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE® 1000 Systems ALB Albumin Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE® 1000 Systems INS Insulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 1000 Immunoassay System — Siemens Medical Solutions Diagnostics Limited
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 0ec87874-25cf-4ba3-91f0-e4f2dca5175e 37 fields · synced Jun 8, 2026