Duns Number:188354831
Device Description: 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predilute 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ACA Negative Control 3. 1x 1.2mL prediluted ACA III Decision Point4. 1x 1.2mL prediluted ACA III Screen Control5. 1x 50mL ACA III Sample Diluent6. 1x 50mL ACA III PBS Concentrate, 20x concentrate7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human IgGAM8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
Catalog Number
-
Brand Name
QUANTA Lite® ACA Screen III
Version/Model Number
708620
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
K953291
Product Code
MID
Product Code Name
System, Test, Anticardiolipin Immunological
Public Device Record Key
31ed8cb1-20f6-412b-9878-a903187664fc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 215 |