Duns Number:557223252
Device Description: 1. HIT- IgG(PF4-H)Cartridges for 25 determinations (Cat No 0009800128) 2. HIT-IgG (PF4-H) 1. HIT- IgG(PF4-H)Cartridges for 25 determinations (Cat No 0009800128) 2. HIT-IgG (PF4-H) Calibaratior 1 (Cat No 0009800129)3. HIT-IgG (PF4-H) Calibaratior 2 (Cat No 0009800130)
Catalog Number
00009800127
Brand Name
HemosIL AcuStar HIT-IgG (PF4-H)
Version/Model Number
0009800127
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
K170854
Product Code
LCO
Product Code Name
PLATELET FACTOR 4 RADIOIMMUNOASSAY
Public Device Record Key
f15d49df-94ef-47d5-a5b1-07ff103d6f40
Public Version Date
July 13, 2021
Public Version Number
3
DI Record Publish Date
July 12, 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 272 |