Duns Number:188354831
Device Description: 1. QUANTA Flash RF IgM Calibrator 1: Two (2) barcode labeled tubes containing 0.3mL predil 1. QUANTA Flash RF IgM Calibrator 1: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgM in stabilizers and preservatives.2. QUANTA Flash RF IgM Calibrator 2: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgM in stabilizers and preservatives.
Catalog Number
-
Brand Name
QUANTA Flash RF IgM Calibrators
Version/Model Number
701341
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JIT
Product Code Name
Calibrator, Secondary
Public Device Record Key
19651aff-e86a-485f-89ec-2725f7eb9457
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 |