Duns Number:010717890
Device Description: The Dip&Spin Urinalysis Control is intended as a control for urinalysis reagent strips, mi The Dip&Spin Urinalysis Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed methods, and as a control for confirmatory tests. It is also intended as a means of validating the processing and centrifugation of patient urine samples prior to microscopic evaluation of urine sediment. The controls are supplied liquid, ready-to-use in two levels. They do not require reconstitution or dilution. They are prepared from human urine to which stabilized human red and white blood cells, calcium oxalate crystals, and other compounds have been added to produce the desired reactions when tested by methods described in the product insert.
Catalog Number
1470-02
Brand Name
Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL
Version/Model Number
1470-02
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K874890,K925256
Product Code
JJY
Product Code Name
Multi-Analyte Controls, All Kinds (Assayed)
Public Device Record Key
36111009-fa7f-49c8-8a6c-6b3dd0c20f12
Public Version Date
March 21, 2019
Public Version Number
1
DI Record Publish Date
March 13, 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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |