Primary Device ID | 00850229007195 |
NIH Device Record Key | cf0a0beb-dcfb-4b57-b57b-302bfc614728 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DriDye 405 |
Version Model Number | 405 |
Catalog Number | E002-405 |
Company DUNS | 071065130 |
Company Name | AWARENESS TECHNOLOGY, INCORPORATED |
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 | 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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850229007195 [Primary] |
JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-11-08 |
Device Publish Date | 2016-06-30 |
00850229007010 - StatFax | 2023-06-13 |
00850229007027 - StatFax | 2023-06-13 |
00850229007034 - StatFax | 2023-06-13 |
00850229007041 - StatFax | 2023-06-13 |
00850229007072 - StatFax | 2023-06-13 Digital Dry Bath |
00850229007089 - StatFax | 2023-06-13 Digital Dry Bath |
00850229007102 - StatFax | 2023-06-13 |
00850229007126 - LumiStat | 2023-06-13 |