Primary Device ID | 00853931008030 |
NIH Device Record Key | 7ca72db7-ca96-42bc-9d73-f446bc3bb06a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Hemolysis and Wash Solution |
Version Model Number | 018431US |
Company DUNS | 607696440 |
Company Name | TOSOH BIOSCIENCE, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | 614-317-1916 |
kimberly.harmeson@tosoh.com | |
Phone | 614-317-1916 |
kimberly.harmeson@tosoh.com | |
Phone | 614-317-1916 |
kimberly.harmeson@tosoh.com | |
Phone | 614-317-1916 |
kimberly.harmeson@tosoh.com | |
Phone | 614-317-1916 |
kimberly.harmeson@tosoh.com | |
Phone | 614-317-1916 |
kimberly.harmeson@tosoh.com | |
Phone | 614-317-1916 |
kimberly.harmeson@tosoh.com | |
Phone | 614-317-1916 |
kimberly.harmeson@tosoh.com | |
Phone | 614-317-1916 |
kimberly.harmeson@tosoh.com | |
Phone | 614-317-1916 |
kimberly.harmeson@tosoh.com | |
Phone | 614-317-1916 |
kimberly.harmeson@tosoh.com | |
Phone | 614-317-1916 |
kimberly.harmeson@tosoh.com | |
Phone | 614-317-1916 |
kimberly.harmeson@tosoh.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00853931008030 [Primary] |
GGK | Products, Red-Cell Lysing Products |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-06-08 |
Device Publish Date | 2018-04-23 |
00853931008009 - Tosoh Automated Glycohemoglobin Analyzer HLC-723G8R | 2018-06-08 Glycated Hemoglobin (HbA1C) Analyzer IVD |
00853931008016 - Glycated Hemoglobin (HbA1C) Analyzer IVD | 2018-06-08 Glycated hemoglobin (HbA1C) analyzer IVD, 90 Sample Loader, Remanufactured |
00853931008023 - Glycated Hemoglobin (HbA1C) Analyser IVD, 290 Loader, Remanufactured | 2018-06-08 Glycated hemoglobin (HbA1C) analyzer IVD, 290 Sample Loader, Remanufactured |
00853931008030 - Hemolysis and Wash Solution | 2018-06-08Red Cell Lysing Reagent |
00853931008030 - Hemolysis and Wash Solution | 2018-06-08 Red Cell Lysing Reagent |