Primary Device ID | 00812137010216 |
NIH Device Record Key | fa1cac92-1905-489f-b411-2f4b56fbf940 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Boule Con-Diff Tri-Level |
Version Model Number | 6 x 4.5mL |
Catalog Number | 501-605 |
Company DUNS | 048144997 |
Company Name | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
Device Count | 6 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | true |
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 | false |
OTC Over-The-Counter | false |
Phone | 8004533328 |
quality@cdsolinc.com | |
Phone | 8004533328 |
quality@cdsolinc.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00812137010216 [Primary] |
GS1 | 00812137011794 [Unit of Use] |
JPK | Mixture, Hematology Quality Control |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-02 |
00812137011299 | For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematolo |
00812137010230 | For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematolo |
00812137010216 | For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematolo |