Duns Number:188354831
Device Description: 1. 1x CCP3 IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted E 1. 1x CCP3 IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted CCP3 IgG ELISA Low Positive4. 1x 1.2mL prediluted CCP3 IgG ELISA High Positive/Calibrator A5. 1x 1.2mL prediluted CCP3 IgG ELISA Calibrator B6. 1x 1.2mL prediluted CCP3 IgG ELISA Calibrator C7. 1x 1.2mL prediluted CCP3 IgG ELISA Calibrator D8. 1x 1.2mL prediluted CCP3 IgG ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL HRP CCP3 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® CCP3 IgG ELISA
Version/Model Number
704535
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
K052264
Product Code
NHX
Product Code Name
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Public Device Record Key
d8681454-3484-4e75-99ad-e66a592c7118
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 |