Aptiva® CTD Essential Calibrators
Basic Information
- Brand Name
- Aptiva® CTD Essential Calibrators
- Primary DI
- 08430793040181
- Version / Model
- 723101
- Company Name
- INOVA DIAGNOSTICS, INC.
- Labeler DUNS
- 188354831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-14
- Public Version
- 1
- Public Version Date
- 2023-12-22
- Public Version Status
- New
- Public Device Record Key
- bb1c59d2-426b-4951-a40b-a44997b7e1ed
Device Description
1. Aptiva CTD Essential Calibrator 1 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 2. Aptiva CTD Essential Calibrator 2 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 3. Aptiva CTD Essential Calibrator 3 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 4. Aptiva CTD Essential Calibrator 4 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 5. Aptiva CTD Essential Calibrator 5 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 6. Aptiva CTD Essential Calibrator 6 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41270 | Multiple antinuclear antibody (ANA) screening 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 screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08430793040181 | GS1 |
Customer Contacts
- Phone
- 1-800-678-0710
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius