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 IgG III Control4. 1x 1.2mL prediluted ACA IgG III Calibrator A5. 1x 1.2mL prediluted ACA IgG III Calibrator B6. 1x 1.2mL prediluted ACA IgG III Calibrator C7. 1x 1.2mL prediluted ACA IgG III Calibrator D8. 1x 1.2mL prediluted ACA IgG III Calibrator E9. 1x 50mL ACA III Sample Diluent10. 1x 50mL ACA III PBS Concentrate, 20x concentrate11. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
Catalog Number
-
Brand Name
QUANTA Lite® ACA IgG III
Version/Model Number
708625
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
K946034
Product Code
MID
Product Code Name
System, Test, Anticardiolipin Immunological
Public Device Record Key
cea28b56-9a35-45a5-a59f-f451f8616e5c
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 |