Duns Number:025460908
Device Description: TEST, DRUG, 12 PANEL, A.D, 25/BX
Catalog Number
MPHD122A3C
Brand Name
Medline
Version/Model Number
MPHD122A3C
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182701,K182701
Product Code
NFT
Product Code Name
TEST, AMPHETAMINE, OVER THE COUNTER
Public Device Record Key
58f42e02-a04f-48ea-99da-093073832457
Public Version Date
October 31, 2022
Public Version Number
4
DI Record Publish Date
March 29, 2022
Package DI Number
20193489017547
Quantity per Package
25
Contains DI Package
10193489017540
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |