FDA UDI
In Commercial Distribution
🇺🇸 United States
RIDA® CCD-Inhibitor
DI: 04049095260049
·
Model: ZA0601
·
R-Biopharm AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RIDA® CCD-Inhibitor
- Primary DI
- 04049095260049
- Version / Model
- ZA0601
- Company Name
- R-Biopharm AG
- Labeler DUNS
- 321850323
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-03
- Public Version
- 1
- Public Version Date
- 2023-07-11
- Public Version Status
- New
- Public Device Record Key
- 5c61c15e-3561-4bcb-a1f4-8a3ddfc40f06
Device Description
The RIDA® CCD-Inhibitor is an accessory for use in in vitro diagnostics for the inhibition of anti-CCD IgE in human serum and plasma.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DHL | Protein, Complement, Antigen, Antiserum, Control | Immunology | 866.4100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53782 | Allergen-specific 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 in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049095260049 | GS1 |