FDA UDI
In Commercial Distribution
🇺🇸 United States
Histofluor® Rodent LKS Fluorescent Antibody Test System
DI: M749120750211
·
Model: 12075-02 (1)
·
IMMUNO CONCEPTS INC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Histofluor® Rodent LKS Fluorescent Antibody Test System
- Primary DI
- M749120750211
- Version / Model
- 12075-02 (1)
- Catalog Number
- 12075-02 (1)
- Company Name
- IMMUNO CONCEPTS INC
- Labeler DUNS
- 038271904
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-09
- Public Version
- 2
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- 4f35da0e-c510-419e-a881-5a8a97ce9db4
Device Description
Rodent Tissue IgG Fluorescent Antibody Reagent 1 x 23ml.
Device Characteristics
- Single Use
- Yes
- 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
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43503 | Human immunoglobulin G (IgG) 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 G (IgG) 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 | M749120750211 | HIBCC |