| Primary Device ID | 04049016152088 |
| NIH Device Record Key | 0fdfcd48-60e4-49f2-8f32-eded6c9ff5cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TITERPLANE set for the incubation of slides with 50 fields |
| Version Model Number | ZZ 9999-0101-19-R |
| Company DUNS | 322209263 |
| Company Name | EUROIMMUN Medizinische Labordiagnostika AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04049016152088 [Primary] |
| PPM | General Purpose Reagent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-10 |
| Device Publish Date | 2025-06-02 |
| 04049016152088 - TITERPLANE set for the incubation of slides with 50 fields | 2025-06-10 |
| 04049016152088 - TITERPLANE set for the incubation of slides with 50 fields | 2025-06-10 |
| 04049016152040 - WASH REAGENT 2 | 2025-05-21 |
| 04049016151876 - Sample buffer 2, Crithidia luciliae sensitive (IFA) | 2025-03-14 |
| 04049016151890 - Sample buffer 2, Crithidia luciliae sensitive (IFA) | 2025-03-14 |
| 04049016151920 - PBS-Tween (IFA) | 2025-03-12 |
| 04049016151883 - Sample buffer (IFA) | 2025-03-06 |
| 04049016151906 - Sample buffer (IFA) | 2025-03-06 |
| 04049016151913 - Sample buffer (IFA) | 2025-03-06 |