| Primary Device ID | 00816879023008 |
| NIH Device Record Key | 0227304f-4661-4a88-94a3-7fa2f2a4b62b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NOVEOS IgE Common Kit |
| Version Model Number | 63140 |
| Company DUNS | 010558476 |
| Company Name | HYCOR BIOMEDICAL LLC |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816879023008 [Primary] |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-19 |
| Device Publish Date | 2021-01-11 |
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| 00816879020557 - Sage, Salvia officinalis | 2022-01-10 |
| 00816879020564 - Saffron | 2022-01-10 |
| 00816879020588 - Pepper, Green, Piper nigrum | 2022-01-10 |
| 00816879020663 - Lime, Citrus aurantiifolia | 2022-01-10 |
| 00816879020816 - Cheese, American (Defatted) | 2022-01-10 |
| 00816879020977 - Cefalexin | 2022-01-10 |
| 00816879022988 - Willow, Salix caprea | 2022-01-10 |