FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DV/DM COV2G/CV2G CAL
DI: 00630414607047
·
Model: 11417772
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- DV/DM COV2G/CV2G CAL
- Primary DI
- 00630414607047
- Version / Model
- 11417772
- Catalog Number
- KC872
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 005088112
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2021-01-22
- Public Version
- 2
- Public Version Date
- 2023-08-11
- Public Version Status
- Update
- Public Device Record Key
- d9dd5144-49e8-4e51-8b36-34d6c7c4a241
- Distribution End Date
- 2023-08-01
Device Description
DV/DM COV2G/CV2G CAL
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
- Yes
- 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 |
|---|---|---|---|---|
| JIT | Calibrator, secondary | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64854 | SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00630414298399 | GS1 | ||||
| Primary | 00630414607047 | GS1 |
Customer Contacts
- Phone
- +1(800)441-9250
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -25 – -15 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – -15 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store Upright