FDA UDI
In Commercial Distribution
🇺🇸 United States
FITC-labelled anti-human IgA
DI: 04049016151593
·
Model: AF 101-0546-R
·
EUROIMMUN Medizinische Labordiagnostika AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FITC-labelled anti-human IgA
- Primary DI
- 04049016151593
- Version / Model
- AF 101-0546-R
- Company Name
- EUROIMMUN Medizinische Labordiagnostika AG
- Labeler DUNS
- 322209263
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-08
- Public Version
- 1
- Public Version Date
- 2024-11-18
- Public Version Status
- New
- Public Device Record Key
- bd021b86-5070-4702-b4e0-d2bd63ecaa39
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- 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 |
|---|---|---|---|---|
| PPM | General Purpose Reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43486 | Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD | One or multiple immunoglobulins sourced from an animal (e.g., goat, sheep, mouse, rabbit) intended to be used in combination with other IVDs for the qualitative and/or quantitative detection of antihuman immunoglobulin A (IgA) antibodies. The immunoglobulin molecules are conjugated or bound by additional substances (e.g., fluorescent markers, peroxidase enzymes) for the detection of immune complexes in clinical specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049016151593 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius