IMMULITE® 2000 Systems Allergen Tube Caps L2ATC
GUDID 00630414965734
IMMULITE® 2000 Systems Allergen Tube Cap
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Chemiluminescent immunoassay analyser IVD, automated| Primary Device ID | 00630414965734 |
| NIH Device Record Key | c7a02bdf-ae11-4eee-9822-3bfb29d548d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMMULITE® 2000 Systems Allergen Tube Caps |
| Version Model Number | 10282837 |
| Catalog Number | L2ATC |
| 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 | false |
| 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 | 00630414965734 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K970227
FDA Product Code
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-02 |
| Device Publish Date | 2020-09-24 |
Devices Manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
| 00630414637877 - Atellica IM HBcT2 | 2024-05-06 Atellica IM HBcT2 (REF) 500T |
| 00630414561226 - ADVIA Centaur® HBcT2 | 2023-06-28 ADVIA Centaur® HBcT2 |
| 00630414210766 - ADVIA Centaur® HBcT2 Quality Control Kit | 2023-06-28 ADVIA Centaur® HBcT2 |
| 00630414604138 - Atellica IM HBcT2 | 2023-06-28 HBc Total 2 (HBcT2) Atellica IM - RGT 100T |
| 00630414604336 - Atellica IM HBcT2 QC | 2023-06-28 HBc Total 2 (HBcT2) Atellica IM - CLT 2 x 2 x 7.0mL |
| 00630414000138 - IMMULITE 2000 rBet v 2 Specific Allergen | 2022-09-20 rBet v 2 Alleren |
| 00630414006246 - IMMULITE 2000 rMal d 1 Specific Allergen | 2022-09-20 rMal d 1 Allergen |
| 00630414006253 - IMMULITE 2000 rPru av 3 Specific Allergen | 2022-09-20 rPru av 3 Allergen |
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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