Primary Device ID | 06438147377732 |
NIH Device Record Key | 36c600ec-87ee-4898-991e-5281f3808c28 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Eonis SCID-SMA kit |
Version Model Number | 3241-001U |
Catalog Number | 3241-001U |
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 |
Storage Environment Temperature | Between -30 Degrees Celsius and -16 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -16 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -16 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -16 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -16 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -16 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -16 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06438147377732 [Primary] |
QUE | Spinal Muscular Atrophy Newborn Screening Test System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-08 |
Device Publish Date | 2022-11-30 |
06438147377756 | The Eonis SCID-SMA kit is a device intended for PCR amplification of sjTREC, KREC, SMN1 and RPP3 |
06438147377732 | The Eonis SCID-SMA kit is a device intended for PCR amplification of sjTREC, KREC, SMN1 and RPP3 |