Duns Number:296822794
Device Description: Helicobacter pylori IgG Ab - IMMULITE - RGT - 200 Tests
Catalog Number
L2KHPG2
Brand Name
IMMULITE® 2000 Systems HPG H.pylori IgG
Version/Model Number
10381336
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
K000463
Product Code
LYR
Product Code Name
Helicobacter pylori
Public Device Record Key
f2d5f828-3053-41b7-a305-ab8581fd4565
Public Version Date
November 18, 2021
Public Version Number
5
DI Record Publish Date
September 24, 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 | 143 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 493 |
| 3 | A medical device with high risk that requires premarket approval | 22 |