Primary Device ID | 05055273201420 |
NIH Device Record Key | b2815b02-0434-498b-ad93-530a6580a032 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CK-MB |
Version Model Number | CK1296 |
Catalog Number | CK1296 |
Company DUNS | 227530649 |
Company Name | RANDOX LABORATORIES LIMITED |
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 | 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 | true |
OTC Over-The-Counter | false |
Phone | +442894451070 |
technical.services@randox.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05055273201420 [Primary] |
CGS | Nad Reduction/Nadh Oxidation, Cpk Or 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 | 2016-09-16 |
05055273213973 | The device is intended for the quantitative in vitro determination of CK-MB concentration in ser |
05055273201444 | The device is intended for the quantitative in vitro determination of CK-MB concentration in ser |
05055273201420 | The device is intended for the quantitative in vitro determination of CK-MB concentration in ser |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CK-MB 73193560 not registered Dead/Abandoned |
AMERICAN HOSPITAL SUPPLY CORPORATION 1981-08-25 |