Duns Number:092815364
Device Description: MERIFLUOR Chlamydia is an in vitro direct immunofluorescent detection procedure for the d MERIFLUOR Chlamydia is an in vitro direct immunofluorescent detection procedure for the detection of Chlamydia trachomatis and Chlamydia psittaci in McCoy cells
Catalog Number
500111
Brand Name
MERIFLUOR Chlamydia
Version/Model Number
500111
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
K830342
Product Code
LKI
Product Code Name
Antisera, Fluorescent, Chlamydia Spp.
Public Device Record Key
5d2ff9be-a9b3-48f4-bcc6-93a6d26426af
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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 | 149 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |
| 3 | A medical device with high risk that requires premarket approval | 1 |