Primary Device ID | 00816426021372 |
NIH Device Record Key | 04b2157a-f511-466c-bc4a-45228a2df243 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | K-ASSAY® Total IgE Control |
Version Model Number | K94C-2M |
Catalog Number | K94C-2M |
Company DUNS | 197934250 |
Company Name | KAMIYA BIOMEDICAL COMPANY, LLC |
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 | 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 | |
Phone | 206-575-8068 |
diagnostics@k-assay.com | |
Phone | 206-575-8068 |
diagnostics@k-assay.com | |
Phone | 206-575-8068 |
diagnostics@k-assay.com | |
Phone | 206-575-8068 |
diagnostics@k-assay.com | |
Phone | 206-575-8068 |
diagnostics@k-assay.com | |
Phone | 206-575-8068 |
diagnostics@k-assay.com | |
Phone | 206-575-8068 |
diagnostics@k-assay.com | |
Phone | 206-575-8068 |
diagnostics@k-assay.com | |
Phone | 206-575-8068 |
diagnostics@k-assay.com | |
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 |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00816426021372 [Primary] |
JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-02-25 |
Device Publish Date | 2019-01-25 |
00816426021389 | For use as a consistent test sample of known concentration for monitoring assay conditions for T |
00816426021372 | For use as a consistent test sample of known concentration for monitoring assay conditions for T |
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 |