Duns Number:188354831
Device Description: 1. 1x PBC Screen IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pr 1. 1x PBC Screen IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted PBC Screen IgG/IgA ELISA Low Positive4. 1x 1.2mL prediluted PBC Screen IgG/IgA ELISA High Positive5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP PBC Screen IgG/IgA Conjugate, (goat), anti-human IgG/IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
Catalog Number
-
Brand Name
QUANTA Lite® PBC Screen IgG/IgA ELISA
Version/Model Number
704560
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
K061842
Product Code
DBM
Product Code Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Public Device Record Key
e36e14a2-6bf2-49b0-b355-4ed60823f1ef
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 |