Duns Number:388240673
Device Description: LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting te LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA 1 Screening Reagent (DRVVT) and LA 2 Confirmation Reagent (DRVVT) from Siemens Healthcare Diagnostics on automated coagulation analyzers
Catalog Number
OQWE11
Brand Name
LA Control Low
Version/Model Number
10446154
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 04, 2019
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K993332,K993332
Product Code
GGC
Product Code Name
CONTROL, PLASMA, ABNORMAL
Public Device Record Key
2cf1b4e8-0ef4-4dad-b5fb-e9e6c9c0ad16
Public Version Date
November 18, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |