Primary Device ID | B103A10CS30021 |
NIH Device Record Key | ad67c049-53d9-4709-b1ce-fda64f5a0cef |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem T |
Version Model Number | CS3002 |
Catalog Number | CS3002 |
Company DUNS | 243942278 |
Company Name | International Point of Care Incorporated |
Device Count | 10 |
DM Exempt | false |
Pre-market Exempt | false |
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 | false |
OTC Over-The-Counter | false |
Phone | 416-847-2777 |
customerservice@ipocdx.com | |
Phone | 416-847-2777 |
customerservice@ipocdx.com | |
Phone | 416-847-2777 |
customerservice@ipocdx.com | |
Phone | 416-847-2777 |
customerservice@ipocdx.com | |
Phone | 416-847-2777 |
customerservice@ipocdx.com | |
Phone | 416-847-2777 |
customerservice@ipocdx.com | |
Phone | 416-847-2777 |
customerservice@ipocdx.com | |
Phone | 416-847-2777 |
customerservice@ipocdx.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B103A10CS30021 [Primary] |
HIBCC | B103CS30020 [Unit of Use] |
JHT | Chromatographic Separation, Cpk Isoenzymes |
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 | 2016-09-15 |
B103A25CS30021 | Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB i |
B103A20CS30021 | Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB i |
B103A10CS30021 | Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB i |