Duns Number:079264306
Device Description: 6-HMU GALC Substrate.Analyte Specific Reagent - Analytical and performance characteristics 6-HMU GALC Substrate.Analyte Specific Reagent - Analytical and performance characteristics are not established.
Catalog Number
2103
Brand Name
Baebies 6-HMU GALC
Version/Model Number
2103
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
Yes
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
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
61964cb8-07eb-47c2-8b60-a90fd2502630
Public Version Date
January 14, 2019
Public Version Number
1
DI Record Publish Date
December 12, 2018
Package DI Number
10819704020262
Quantity per Package
12
Contains DI Package
00819704020265
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |