FDA UDI
In Commercial Distribution
🇺🇸 United States
Aptiva® APS IgM Reagent
DI: 08430793040853
·
Model: 725140
·
INOVA DIAGNOSTICS, INC.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Aptiva® APS IgM Reagent
- Primary DI
- 08430793040853
- Version / Model
- 725140
- Company Name
- INOVA DIAGNOSTICS, INC.
- Labeler DUNS
- 188354831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-11
- Public Version
- 2
- Public Version Date
- 2025-08-14
- Public Version Status
- Update
- Public Device Record Key
- 8d501857-2123-47a9-b0dd-d2d2b906920c
Device Description
1.Aptiva APS IgM Reagent Cartridge -APS IgM Beads (1x0.5mL) -Assay Buffer (1x17mL) -PE Tracer IgM (1x17mL) -Hydration Buffer (1x6.5mL)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | Immunology | 866.5660 | 2 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54871 | Anticardiolipin antibody IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to cardiolipin in a clinical specimen, using a fluorescent immunoassay method. | No | Active |
| 54875 | Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to cardiolipin-B2-glycoprotein I complex in a clinical specimen, using a fluorescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08430793040853 | GS1 |
Customer Contacts
- Phone
- 1-800-678-0710
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223093 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius