FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel
DI: 00813382010075
·
Model: 85003
·
Minaris Medical America, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel
- Primary DI
- 00813382010075
- Version / Model
- 85003
- Catalog Number
- 85003
- Company Name
- Minaris Medical America, Inc.
- Labeler DUNS
- 102113867
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-19
- Public Version
- 6
- Public Version Date
- 2023-08-03
- Public Version Status
- Update
- Public Device Record Key
- 3091c1c7-e253-4619-85e5-8c8f957893a2
- Distribution End Date
- 2017-01-16
Device Description
KIT, OPTIGEN Universal Panel 20
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
- Yes
- 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 |
|---|---|---|---|---|
| DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | Immunology | 866.5750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61955 | Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to screen for allergies associated with certain conditions (e.g., food intolerance). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813382010075 | GS1 |
Customer Contacts
- Phone
- +1(650)961-5501 ext. 686
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051677 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 10 Degrees Celsius