Duns Number:188354831
Device Description: 1. QUANTA Flash RF IgM Reagent Cartridge contains the following reagents for 100 determina 1. QUANTA Flash RF IgM Reagent Cartridge contains the following reagents for 100 determinations:a. Rabbit pAb coated paramagnetic beads.b. Assay buffer - colored pink, containing proteing stabilizers and preservatives.c. Tracer IgM - Isoluminol labeled anti-human IgM antibody, containing buffer, protein stabilizers and preservatives.
Catalog Number
-
Brand Name
QUANTA Flash RF IgM Reagents
Version/Model Number
701340
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
K190088
Product Code
DHR
Product Code Name
System, Test, Rheumatoid Factor
Public Device Record Key
7a388e60-7dd7-4165-9124-eb7f69fc977c
Public Version Date
September 30, 2019
Public Version Number
1
DI Record Publish Date
September 20, 2019
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 |