Primary Device ID | 00816426021082 |
NIH Device Record Key | cc12cca9-a590-4457-996a-47ca75863e1f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | K-ASSAY® Fibrinogen Calibrator |
Version Model Number | KAI-136C |
Catalog Number | KAI-136C |
Company DUNS | 197934250 |
Company Name | KAMIYA BIOMEDICAL COMPANY, LLC |
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 |
Phone | 206-575-8068 |
diagnostics@k-assay.com | |
Phone | 206-575-8068 |
diagnostics@k-assay.com | |
Phone | 206-575-8068 |
diagnostics@k-assay.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00816426021082 [Primary] |
GIS | Test, Fibrinogen |
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 | 2017-01-13 |
00816426021082 | For the calibration of the K-ASSAY® Fibrinogen assay. |
00816426020658 | For the calibration of the K-ASSAY® Fibrinogen assay. |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() K-ASSAY 75060842 2045784 Live/Registered |
KAMIYA BIOMEDICAL COMPANY, LLC 1996-02-22 |
![]() K-ASSAY 74707766 2011686 Live/Registered |
KAMIYA BIOMEDICAL COMPANY, LLC 1995-07-28 |