Duns Number:067647321
Device Description: The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitoni The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum. This assay is intended for in vitro diagnostic use.
Catalog Number
-
Brand Name
Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]
Version/Model Number
7024
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K982491
Product Code
JKR
Product Code Name
Radioimmunoassay, Calcitonin
Public Device Record Key
80b7c136-6a22-4d99-9425-adaf254994f2
Public Version Date
July 09, 2020
Public Version Number
1
DI Record Publish Date
July 01, 2020
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |