Duns Number:700853096
Device Description: Calibrator L (1 mL × 1), Calibrator H (1 mL × 1)
Catalog Number
G252GA
Brand Name
Calibrator for Lucica® Glycated Albumin-L
Version/Model Number
G252GA
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
-
Product Code
JIT
Product Code Name
Calibrator, secondary
Public Device Record Key
61b99519-f4e1-4831-9ac3-75b6ab5309de
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 22, 2019
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |