FDA UDI
In Commercial Distribution
🇺🇸 United States
CLA® Allergen-Specific IgE Assay - Moderate Food Panel
DI: 00813382010174
·
Model: 84518
·
Minaris Medical America, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CLA® Allergen-Specific IgE Assay - Moderate Food Panel
- Primary DI
- 00813382010174
- Version / Model
- 84518
- Catalog Number
- 84518
- Company Name
- Minaris Medical America, Inc.
- Labeler DUNS
- 102113867
- Distribution Status
- 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
- 0ca4eb16-bcf8-4e6b-9105-9fc93a3450d9
Device Description
KIT, Moderate Food
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 | 00813382010174 | GS1 |
Customer Contacts
- Phone
- +1(650)961-5501 ext. 686
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 10 Degrees Celsius