Primary Device ID | 00851445007204 |
NIH Device Record Key | c9178956-abe3-43ee-a28a-bad9e2c55b1b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GENCHEM™ Direct Bilirubin Reagent |
Version Model Number | GEN-DBILI R2 |
Catalog Number | GEN-DBILI R2 |
Company DUNS | 193856866 |
Company Name | GENCHEM INC |
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 | false |
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 | true |
OTC Over-The-Counter | false |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org | |
Phone | +1(714)529-7125 |
lorlow@genchem.org |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00851445007204 [Primary] |
CIG | DIAZO COLORIMETRY, BILIRUBIN |
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 | 2016-09-19 |
00851445007204 | DIRECT BILIRUBIN R2 |
00851445007198 | DIRECT BILIRUBIN R1 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GENCHEM 76171200 not registered Dead/Abandoned |
Novasite Pharmaceuticals, Inc. 2000-11-22 |