Duns Number:051624070
Device Description: Amplichek I Level 3 (An assayed nucleic acid control.)
Catalog Number
12000530
Brand Name
Amplichek
Version/Model Number
12000530
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
K152679
Product Code
PMN
Product Code Name
Assayed external control material for microbiology nucleic acid amplification (NAT) assays
Public Device Record Key
738f3d2a-a145-4948-a9d6-84722f51d7ac
Public Version Date
January 23, 2020
Public Version Number
4
DI Record Publish Date
September 19, 2016
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 | 511 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 428 |
| U | Unclassified | 1 |