Duns Number:064608573
Device Description: Calibrator O Atellica IM - CAL (2PK) 2 x 2 x 1.0 mL
Catalog Number
10995516
Brand Name
Atellica IM Calibrator O
Version/Model Number
10995516
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K003291,K003291
Product Code
JZO
Product Code Name
SYSTEM, TEST, THYROID AUTOANTIBODY
Public Device Record Key
674fa560-a567-413c-8eeb-4cce0965fc0d
Public Version Date
November 18, 2021
Public Version Number
5
DI Record Publish Date
December 27, 2017
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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |