FDA UDI
In Commercial Distribution
🇺🇸 United States
Atellica IM Calibrator D
DI: 00630414598376
·
Model: 10995510
·
Siemens Healthcare Diagnostics Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Atellica IM Calibrator D
- Primary DI
- 00630414598376
- Version / Model
- 10995510
- Catalog Number
- 10995510
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2017-12-27
- Public Version
- 5
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- 57e5d388-13e2-4c44-9ae4-1034f1de36a8
Device Description
Calibrator D - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LOJ | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER | Immunology | 866.6010 | 2 |
| LOK | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38221 | Multiple tissue-associated protein/tumour marker IVD, calibrator | A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple proteins or tumour markers associated with specific tissues in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414598376 | GS1 | ||||
| Unit of Use | 00630414190815 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020806 | 000 |
| P930036 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store upright
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius