| Primary Device ID | 04987481164420 |
| NIH Device Record Key | b2fd4d72-ce8c-441f-8ad3-33d3802e864e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | uTASWako Chip Cassette |
| Version Model Number | 993-61601 |
| Catalog Number | 993-61601 |
| Company DUNS | 690598875 |
| Company Name | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
| Device Count | 5 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987481164420 [Unit of Use] |
| GS1 | 10856626006080 [Previous] |
| GS1 | 14987481164427 [Primary] |
| NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-02 |
| Device Publish Date | 2020-10-23 |
| 10856626006080 | The uTASWako chip cassette is designed to be used for the assays on the uTASWako i30. |
| 04987481164420 | The uTASWako chip cassette is designed to be used for the assays on the uTASWako i30. |