FDA UDI
In Commercial Distribution
🇺🇸 United States
QUANTA Flash® β2GPI IgM Controls
DI: 08426950595038
·
Model: 701252
·
INOVA DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QUANTA Flash® β2GPI IgM Controls
- Primary DI
- 08426950595038
- Version / Model
- 701252
- 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
- 6282789f-5712-4252-a08d-621fdb29abdd
Device Description
1. QUANTA Flash ß2GP1 IgM Low Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albimun, stabilizers and preservative. 2. QUANTA Flash ß2GP1 IgM High Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albumin, stabilizers and preservative.
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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41276 | Beta-2-glycoprotein I antibody IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to beta-2-glycoprotein I in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950595038 | GS1 |
Customer Contacts
- Phone
- 1-800-545-9495
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091556 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius