Identity
- Trade Name
- IMMULITE® 1000 Immunoassay System FDA UDI
- Generic Name
- Chemiluminescent immunoassay analyser IVD FDA UDI
- Device Name
- IMMULITE® 1000 Instrument, 110 VOLT FDA UDI
- Model / Reference
- 10380058 FDA UDI
- Description
- IMMULITE® 1000 Instrument, 110 VOLT FDA UDI
Identifiers
- Catalog Number
- 030006-03 FDA UDI
- Primary DI / UDI-DI
- 00630414947440 FDA UDI
- 510(k) Number
- K022603 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Chemiluminescent immunoassay analyser IVD 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Chemiluminescent immunoassay analyser IVD
IMMULITE® 1000 Immunoassay System by Siemens Medical Solutions Diagnostics Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Chemiluminescent immunoassay analyser IVD.
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- Atellica IM 1300 Analyzer — Siemens Healthcare Diagnostics · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Atellica IM 1300 Analyzer — Siemens Healthcare Diagnostics · Class I
- Alinity — Abbott Laboratories, Inc. · N
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® 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
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 Medical Solutions Diagnostics Limited
Sources (1)
- FDA UDI 7c197622-ae0e-4ea8-8ea5-de23e9e2a79d 36 fields · synced May 30, 2026