Primary Device ID | 06438147331802 |
NIH Device Record Key | 558bfbeb-a479-41e4-a083-bc08323f596a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EnLite Neonatal TREC kit |
Version Model Number | 3401-001U |
Catalog Number | 3401-001U |
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 | 06438147331802 [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 |