Primary Device ID | 06438147292486 |
NIH Device Record Key | a57e2204-71ed-42ea-a179-852e371eb23f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AutoDELFIA Neonatal 17α-OH-progesterone kit |
Version Model Number | B024-112 |
Catalog Number | B024-112 |
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 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06438147292486 [Primary] |
JLX | Radioimmunoassay, 17-Hydroxyprogesterone |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-12-17 |
Device Publish Date | 2018-11-16 |
06438147292523 | For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood. |
06438147292486 | For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood. |
06438147292479 | For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood. |