Identity
- Trade Name
- IMMULITE® INS Control Insulin FDA UDI
- Generic Name
- Insulin IVD, control FDA UDI
- Device Name
- Insulin Module - IMMULITE - CTL - 2x5mL FDA UDI
- Model / Reference
- 10286614 FDA UDI
- Description
- Insulin Module - IMMULITE - CTL - 2x5mL FDA UDI
Identifiers
- Catalog Number
- LINCM FDA UDI
- Primary DI / UDI-DI
- 00630414998954 FDA UDI
- 510(k) Number
- K022603 FDA UDI
- FDA Product Code
- CFP FDA UDI
- GMDN Term
- Insulin IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1405 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: Insulin IVD, control
IMMULITE® INS Control Insulin by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Diazyme — Diazyme Laboratories, Inc.
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- ARCHITECT — Abbott · Class I
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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® Systems ALB CONTROL Albumin — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI a0868b7e-0b28-41f0-9132-1df1d84ab57d 37 fields · synced Jun 1, 2026