Duns Number:557223252
Device Description: HemosIL Liquid Antithrombin 1. 4 x 2 mL Factor Xa Reagent (0020300410)2. 4 x 2 mL Chromoge HemosIL Liquid Antithrombin 1. 4 x 2 mL Factor Xa Reagent (0020300410)2. 4 x 2 mL Chromogenic substrate (0020300420)
Catalog Number
00020300440
Brand Name
HemosIL Liquid Antithrombin
Version/Model Number
0020300440
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
K062431
Product Code
JBQ
Product Code Name
Antithrombin Iii Quantitation
Public Device Record Key
7fa22b7a-37c9-4f5f-9ef9-680a394f4a8a
Public Version Date
July 13, 2021
Public Version Number
3
DI Record Publish Date
January 29, 2021
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. | 272 |