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
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| 00630414608761 - Atellica IM aTPOII | 2026-02-03 Anti-Thyroid Peroxidase II (aTPOII) Atellica IM - RGT 500T |
| 00630414608891 - Atellica IM aTPOII QC | 2026-02-03 aTPOII Atellica IM - CT: 2 x 3 x 1.0 mL |
| 00630414609492 - Atellica IM aTPOII Diluent | 2026-02-03 aTPOII Atellica IM - Diluent 2 x 5.0 mL |
| 00630414608570 - ADVIA Centaur aTPOII | 2026-01-08 Anti-Thyroid Peroxidase II (aTPOII) ADVIA Centaur - RGT 500T |
| 00630414608587 - ADVIA Centaur aTPOII QC | 2026-01-08 aTPOII ADVIA Centaur - CTL 2 x 3 x 1.0 mL |
| 00630414608747 - ADVIA Centaur aTPOII | 2026-01-08 Anti-Thyroid Peroxidase II (aTPOII) ADVIA Centaur - RGT 100T |
| 00630414609409 - ADVIA Centaur aTPOII Diluent | 2026-01-08 aTPOII ADVIA Centaur - Diluent 2 x 5.0 mL |
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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