FDA UDI
In Commercial Distribution
🇺🇸 United States
IgE
DI: 05055273203929
·
Model: IE7308
·
RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IgE
- Primary DI
- 05055273203929
- Version / Model
- IE7308
- Catalog Number
- IE7308
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 83051e12-3208-45f3-a9b0-220f2a73114d
Device Description
An IgE test system is a device intended for the quantitative in vitro determination of immunoglobulin E (IgE) concentration in human serum or plasma
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 |
|---|---|---|---|---|
| DGC | Ige, Antigen, Antiserum, Control | Immunology | 866.5510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43796 | Allergen-specific/total immunoglobulin E (IgE) antibody IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergens and total immunoglobulin E (IgE total) antibodies in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273203929 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010855 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from light