IMMULITE® 2000 Systems Reaction Tubes LRXT
GUDID 00630414954547
Gear Driven Reaction Tubes 1000 - IMMULITE - CONS - 1000 Pieces
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
General laboratory container, single-use, non-sterile| Primary Device ID | 00630414954547 |
| NIH Device Record Key | 3892056c-e895-4a01-9a33-79816e297178 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMMULITE® 2000 Systems Reaction Tubes |
| Version Model Number | 10385206 |
| Catalog Number | LRXT |
| Company DUNS | 296822794 |
| Company Name | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414954547 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K952516
FDA Product Code
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| JKA | Tubes, vials, systems, serum separators, blood collection |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
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| 00630414238425 - Atellica IM Tg | 2025-09-30 Thyroglobulin (Tg) - Atellica IM - RGT - 500T |
| 00630414637877 - Atellica IM HBcT2 | 2024-05-06 Atellica IM HBcT2 (REF) 500T |
Trademark Results [IMMULITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMMULITE 98891511 not registered Live/Pending |
Siemens Healthcare Diagnostics Inc. 2024-12-09 |
 IMMULITE 74098401 1653588 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1990-09-19 |
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