| Primary Device ID | 04049016108849 |
| NIH Device Record Key | 458c668b-1ffa-4e38-9180-a0ace537bcc5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EUROPLUS Granulocyte Mosaic 25 EUROPattern |
| Version Model Number | FC 1201-1010-25 |
| Company DUNS | 322209263 |
| Company Name | EUROIMMUN Medizinische Labordiagnostika AG |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04049016108849 [Primary] |
| PIV | Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-06-04 |
| 04049016135968 | FC 1201-18010-25 |
| 04049016135890 | FC 1201-12010-25 |
| 04049016135883 | FC 1201-2450-25 |
| 04049016119920 | FC 1201-1050-25 |
| 04049016108863 | FC 1201-2010-25 |
| 04049016108856 | FC 1201-2005-25 |
| 04049016108849 | FC 1201-1010-25 |
| 04049016108832 | FC 1201-1005-25 |