Duns Number:368646046
Device Description: Actim PROM test pouch. Each pouch includes:- One tube of Specimen Extraction Solution (0.5 Actim PROM test pouch. Each pouch includes:- One tube of Specimen Extraction Solution (0.5 mL). This phosphate-buffered solution contains bovine serum albumin (BSA), protease inhibitors and preservatives.- One dipstick in a sealed aluminum foil pouch with desiccant.- One sterile polyester swab for specimen collection.
Catalog Number
-
Brand Name
Actim PROM
Version/Model Number
30821ETUS
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
K123986,K123986,K123986
Product Code
OAM
Product Code Name
Immunoassay, Insulin-Like Growth Factor Binding Protein-1
Public Device Record Key
7c9fad6a-4b68-4a70-9b02-8a929f7c9e57
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
February 28, 2019
Package DI Number
06430030990615
Quantity per Package
20
Contains DI Package
06430030990714
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
20 tests kit box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |