FDA UDI
In Commercial Distribution
🇺🇸 United States
ImmunoCAP Specific IgE 0-100
DI: 07333066019666
·
Model: 10-9462-02
·
Phadia AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ImmunoCAP Specific IgE 0-100
- Primary DI
- 07333066019666
- Version / Model
- 10-9462-02
- Catalog Number
- 10-9462-02
- Company Name
- Phadia AB
- Labeler DUNS
- 354019424
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-26
- Public Version
- 3
- Public Version Date
- 2023-08-03
- Public Version Status
- Update
- Public Device Record Key
- 98b49153-2746-452c-8c28-3acfa77506fe
Device Description
Contains one bottle of Specific IgE Conjugate and two vials of each Specific IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgE method.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| DHB | System, test, radioallergosorbent (rast) immunological | Immunology | 866.5750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53781 | Allergen-specific immunoglobulin E (IgE) 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 immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using an enzyme immunoassay (EIA) 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 | 07333066019666 | GS1 |
Customer Contacts
- Phone
- +469999999999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051218 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius