Duns Number:188354831
Device Description: 1. Aptiva Celiac IgG Reagent Cartridge contains reagents to process 200 samples.a. tTG, DG 1. Aptiva Celiac IgG Reagent Cartridge contains reagents to process 200 samples.a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives.c. PE Tracer IgG – PE labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative.d. Rehydration Buffer - containing protein stabilizers and preservatives
Catalog Number
-
Brand Name
Aptiva® Celiac Disease IgG Reagent
Version/Model Number
724100
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
K200230
Product Code
MST
Product Code Name
Antibodies, Gliadin
Public Device Record Key
fc114443-0242-49f3-8666-abeb86f61eaf
Public Version Date
June 06, 2022
Public Version Number
1
DI Record Publish Date
May 27, 2022
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 215 |