Duns Number:061446282
Device Description: CMT Plates are intended to be used in hemagglutination assays on Immucor automated instrum CMT Plates are intended to be used in hemagglutination assays on Immucor automated instruments. CMT Plates are composed of micro-wells coated to block the nonspecific adsorption of red blood cells or serum proteins to the plastic wells. CMT Plates are supplied in a plate format. Each plate has twelve strips on a support frame and each strip has eight micro-wells. Strips can be used individually or in multiples. This product configuration is forty (40) microplates.
Catalog Number
0089000
Brand Name
CMT Plates
Version/Model Number
0089000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BK070016
Product Code
KSZ
Product Code Name
System, Test, Automated Blood Grouping And Antibody
Public Device Record Key
6b9436b2-7dec-4976-ba46-35f4048434d4
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
April 18, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |
| U | Unclassified | 3 |