FDA UDI
In Commercial Distribution
🇺🇸 United States
QUANTA Lite® ACA IgM III ELISA Bulk Pack
DI: 08426950594536
·
Model: 708630.10
·
INOVA DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QUANTA Lite® ACA IgM III ELISA Bulk Pack
- Primary DI
- 08426950594536
- Version / Model
- 708630.10
- Company Name
- INOVA DIAGNOSTICS, INC.
- Labeler DUNS
- 188354831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 60210948-3f70-4866-8657-09aacb9d2764
Device Description
1. 10x ACA IgM III ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgM III Control 4. 5x 1.2mL prediluted ACA IgM III Calibrator A 5. 5x 1.2mL prediluted ACA IgM III Calibrator B 6. 5x 1.2mL prediluted ACA IgM III Calibrator C 7. 5x 1.2mL prediluted ACA IgM III Calibrator D 8. 5x 1.2mL prediluted ACA IgM III Calibrator E 9. 9x 50mL ACA III Sample Diluent 10. 10x 50mL ACA III PBS Concentrate, 20x concentrate 11. 10x 10mL HRP ACA IgM Conjugate, (goat), anti-human IgM 12. 10x 10mL TMB Chromogen 13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54870 | Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) | 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 an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950594536 | GS1 |
Customer Contacts
- Phone
- 1-800-545-9495
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K946385 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius