Duns Number:188354831
Device Description: 1. 1x RF IgM ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELI 1. 1x RF IgM ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted RF IgM ELISA Calibrator A4. 1x 1.2mL prediluted RF IgM ELISA Calibrator B5. 1x 1.2mL prediluted RF IgM ELISA Calibrator C6. 1x 1.2mL prediluted RF IgM ELISA Calibrator D7. 1x 1.2mL prediluted RF IgM ELISA Calibrator E8. 1x 1.2mL prediluted RF IgM ELISA Control9. 1x 50mL HRP Sample Diluent10.1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL HRP IgM Conjugate, (goat), anti-human IgM12.1x 10mL TMB Chromogen13.1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
Catalog Number
-
Brand Name
QUANTA Lite® RF IgM ELISA
Version/Model Number
708690
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
K971614
Product Code
DHR
Product Code Name
System, Test, Rheumatoid Factor
Public Device Record Key
c04cadc2-6196-44d5-bdf3-a001f96a37de
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 |