FDA UDI
In Commercial Distribution
🇺🇸 United States
IMMCO DIAGNOSTICS
DI: 00845714002960
·
Model: 5308
·
IMMCO DIAGNOSTICS, INC.
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IMMCO DIAGNOSTICS
- Primary DI
- 00845714002960
- Version / Model
- 5308
- Catalog Number
- 5308
- Company Name
- IMMCO DIAGNOSTICS, INC.
- Labeler DUNS
- 079935300
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-27
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 0ecd3c21-cbf6-4e2f-925a-3c2620ae96e8
Device Description
Serum Diluent
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 |
| MST | Antibodies, Gliadin | Immunology | 866.5750 | 2 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | Immunology | 866.5660 | 2 |
| DHR | System, Test, Rheumatoid Factor | Immunology | 866.5775 | 2 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | Immunology | 866.5100 | 2 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | Immunology | 866.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58208 | Buffered sample diluent IVD, manual | A buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845714002960 | GS1 |
Customer Contacts
- Phone
- 1-800-537-8378
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 60 ml |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius