Identity
- Trade Name
- IMMULITE® 2000 Systems HCG Sample Diluent FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- HCG Sample Diluent - IMMULITE - 1x50mL FDA UDI
- Model / Reference
- 10387051 FDA UDI
- Description
- HCG Sample Diluent - IMMULITE - 1x50mL FDA UDI
Identifiers
- Catalog Number
- L2CGZ FDA UDI
- Primary DI / UDI-DI
- 00630414953861 FDA UDI
- 510(k) Number
- K990222 FDA UDI
- FDA Product Code
- DHA FDA UDI
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 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: Buffered sample diluent IVD
IMMULITE® 2000 Systems HCG Sample Diluent by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Buffered sample diluent IVD.
- ADVIA Centaur® ThCG DIL — Siemens Healthcare Diagnostics · Class II
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- Dimension® Sample Diluent — Siemens Healthcare Diagnostics · Class II
- Lumipulse G Specimen Diluent 2 — FUJIREBIO INC. · Class I
- ADVIA Centaur® T4 DIL — Siemens Healthcare Diagnostics · Class II
- Dimension® Purified Water Diluent — Siemens Healthcare Diagnostics · Class I
- ADVIA Centaur® VitD Diluent Bottle — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
Cleared under the same submission
K990222 also covers:
- IMMULITE® 2000 Systems HCG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems HCG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems HCG HCG Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE® 1000 Systems HCG Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE® 1000 Systems HCG Sample 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 9a85f8a0-a49d-4ea4-a100-5adf573a937f 37 fields · synced May 30, 2026