FDA UDI
In Commercial Distribution
🇺🇸 United States
IMMCO DIAGNOSTICS
DI: 00845714002182
·
Model: 2100
·
IMMCO DIAGNOSTICS, INC.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IMMCO DIAGNOSTICS
- Primary DI
- 00845714002182
- Version / Model
- 2100
- Catalog Number
- 2100
- Company Name
- IMMCO DIAGNOSTICS, INC.
- Labeler DUNS
- 079935300
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- 5a594499-9597-4018-9303-956aee89f905
Device Description
IgG FITC Conjugate w/ Evans Blue
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | Immunology | 866.5660 | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | Immunology | 866.5100 | 2 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | Immunology | 866.5660 | 2 |
| LKJ | Antinuclear Antibody, Antigen, Control | Immunology | 866.5100 | 2 |
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 | 00845714002182 | GS1 |
Customer Contacts
- Phone
- 1-800-537-8378
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 5 ml |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius