FDA UDI
In Commercial Distribution
🇺🇸 United States
IMMCO DIAGNOSTICS
DI: 00845714002786
·
Model: 2316
·
IMMCO DIAGNOSTICS, INC.
Product Codes
8
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IMMCO DIAGNOSTICS
- Primary DI
- 00845714002786
- Version / Model
- 2316
- Catalog Number
- 2316
- Company Name
- IMMCO DIAGNOSTICS, INC.
- Labeler DUNS
- 079935300
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-09
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- e15339ca-997c-4b56-ae6f-d1d1959b7c87
Device Description
Stop Solution
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 |
|---|---|---|---|---|
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | Immunology | 866.5660 | 2 |
| MST | Antibodies, Gliadin | Immunology | 866.5750 | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | Immunology | 866.5660 | 2 |
| MID | System, Test, Anticardiolipin Immunological | Immunology | 866.5660 | 2 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | Immunology | 866.5100 | 2 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | Immunology | 866.5100 | 2 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | Immunology | 866.5100 | 2 |
| DHR | System, Test, Rheumatoid Factor | Immunology | 866.5775 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58238 | Sulphuric acid stop solution reagent IVD | A dilute sulphuric acid solution intended to be used to stop enzymatic activity or further development of reactions during the final processing steps of an enzyme immunoassay method, when testing clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845714002786 | GS1 |
Customer Contacts
- Phone
- 1-800-537-8378
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 12 ml |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius