Duns Number:188354831
Device Description: The Celiac Disease IgG Calibrators include antibodies to tTG and DGP.1. Aptiva Celiac IgG The Celiac Disease IgG Calibrators include antibodies to tTG and DGP.1. Aptiva Celiac IgG Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. 2. Aptiva Celiac IgG Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives.3. Aptiva Celiac IgG Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives.
Catalog Number
-
Brand Name
Aptiva® Celiac Disease IgG Calibrators
Version/Model Number
724101
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
-
Product Code
JIX
Product Code Name
Calibrator, Multi-Analyte Mixture
Public Device Record Key
1e92ac96-224d-4b81-9220-e7c97205df03
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 |