K-ASSAY® Apo AI / B Control K310C-4M
GUDID 00816426021648
For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
KAMIYA BIOMEDICAL COMPANY, LLC
Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control Multiple apolipoprotein IVD, control| Primary Device ID | 00816426021648 |
| NIH Device Record Key | d88a50ca-8947-4402-aba1-6bed07e98a07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-ASSAY® Apo AI / B Control |
| Version Model Number | K310C-4M |
| Catalog Number | K310C-4M |
| 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 |
Customer Support Contacts
| 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 | |
| Phone | 206-575-8068 |
| diagnostics@k-assay.com |
Operating and Storage Conditions
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816426021648 [Primary] |
FDA Product Code
| JJY | Multi-Analyte Controls, All Kinds (Assayed) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-05 |
| Device Publish Date | 2020-12-28 |
On-Brand Devices [K-ASSAY® Apo AI / B Control]
| 00816426021648 | For use as a consistent test sample of known concentration for monitoring assay conditions for A |
| 00816426021631 | For use as a consistent test sample of known concentration for monitoring assay conditions for A |
Trademark Results [K-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 |
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