Primary Device ID | 10888234000761 |
NIH Device Record Key | c203b357-0827-47c8-beff-d8e411371052 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Anti-k |
Version Model Number | 0007537 |
Catalog Number | 0007537 |
Company DUNS | 061446282 |
Company Name | IMMUCOR, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
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 | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-855-466-8267 |
tech_support@immucor.com |
Storage Environment Temperature | Between 1 Degrees Celsius and 10 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10888234000761 [Primary] |
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 | 2014-11-04 |
10888234001836 | This polyclonal reagent is used for the detection of the K antigen (of the Kell blood group syst |
10888234000761 | This reagent is used for the detection of the k antigen on red blood cells by tube test. This pr |