FDA UDI
In Commercial Distribution
🇺🇸 United States
FLEX Negative Control Mo Cocktail of Mo IgG1, IgG2a, IgG2b, IgG3, IgM RTU (Link)
DI: 05700571101773
·
Model: IR750
·
AGILENT TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FLEX Negative Control Mo Cocktail of Mo IgG1, IgG2a, IgG2b, IgG3, IgM RTU (Link)
- Primary DI
- 05700571101773
- Version / Model
- IR750
- Company Name
- AGILENT TECHNOLOGIES, INC.
- Labeler DUNS
- 084963177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-17
- Public Version
- 2
- Public Version Date
- 2020-12-07
- Public Version Status
- Update
- Public Device Record Key
- cd82e9a0-2e7d-4b83-800e-bf97beb846ce
Device Description
FLEX Negative Control Mouse Cocktail of mouse IgG1, IgG2a, IgG2b, IgG3 and IgM Ready-to-Use (Link)
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | Hematology | 864.1860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57776 | Negative control immunoglobulin IVD | A material containing immunoglobulin intended to be used in place of a primary antibody as a negative control to verify the performance of an assay that utilizes antibodies (e.g., immunoassay, immunohistochemistry or flow cytometry) and is performed on biological tissues or clinical specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700571101773 | GS1 |
Customer Contacts
- Phone
- +1-805-566-6655
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 80-120 Tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius