FDA UDI
In Commercial Distribution
🇺🇸 United States
QUANTA Lite® M2 EP (MIT3) ELISA Bulk Pack
DI: 08426950596301
·
Model: 704540.10
·
INOVA DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QUANTA Lite® M2 EP (MIT3) ELISA Bulk Pack
- Primary DI
- 08426950596301
- Version / Model
- 704540.10
- 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
- 9011b168-ecab-4e3c-8d8b-339791155b06
Device Description
1. 10x M2 EP (MIT3) ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted M2 EP (MIT3) ELISA Low Positive 4. 5x 1.2mL prediluted M2 EP (MIT3) ELISA High Positive 5. 9x 50mL HRP Sample Diluent 6. 10x 25mL HRP Wash Concentrate, 40x concentrate 7. 10x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 10x 10mL TMB Chromogen 9. 10 x10mL 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 |
|---|---|---|---|---|
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | Immunology | 866.5090 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55032 | Mitochondrial antibody M2 (anti-Mi2) 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 antibodies to mitochondria M2 (anti-Mi2) 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 | 08426950596301 | GS1 |
Customer Contacts
- Phone
- 1-800-545-9495
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052262 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius