Duns Number:012430880
Device Description: Handheld portable analyzer for Lipid and Glucose Testing, Blood Sample used is 40ul
Catalog Number
5701036
Brand Name
Henry Schein
Version/Model Number
5701036
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
Yes
FDA Premarket Submission
-
Product Code
LCP
Product Code Name
ASSAY, GLYCOSYLATED HEMOGLOBIN
Public Device Record Key
a3277d49-85a0-4666-a40e-21bf1f901b25
Public Version Date
June 15, 2018
Public Version Number
1
DI Record Publish Date
May 15, 2018
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |