| Primary Device ID | 06438147331819 |
| NIH Device Record Key | 3f324d6e-5f32-4110-8cb7-cfa63d9448f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EnLite Neonatal TREC kit |
| Version Model Number | 3402-001U |
| Catalog Number | 3402-001U |
| Company DUNS | 540156544 |
| Company Name | Wallac Oy |
| 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 | false |
| 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 |
| Storage Environment Temperature | Between -30 Degrees Celsius and -16 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06438147331819 [Primary] |
| PJI | Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-02-02 |
| 06438147331826 | Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dr |
| 06438147331819 | Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dr |
| 06438147331802 | Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dr |