FDA UDI
In Commercial Distribution
🇺🇸 United States
MAGE-A4 IHC 1F9 pharmDx
DI: 05700573007400
·
Model: SK032
·
AGILENT TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MAGE-A4 IHC 1F9 pharmDx
- Primary DI
- 05700573007400
- Version / Model
- SK032
- Company Name
- AGILENT TECHNOLOGIES, INC.
- Labeler DUNS
- 084963177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-01
- Public Version
- 1
- Public Version Date
- 2024-10-09
- Public Version Status
- New
- Public Device Record Key
- 9c30af27-07a0-4aea-92f2-df2c723166fd
Device Description
MAGE-A4 IHC 1F9 pharmDx
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| SBL | Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 | Hematology | 864.1860 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57370 | Melanoma-associated antigen (MAGE) IVD, kit, enzyme immunohistochemistry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of melanoma-associated antigen (MAGE) in a clinical specimen, using an enzyme immunohistochemistry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700573007400 | GS1 |
Customer Contacts
- Phone
- +1-800-227-9770
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P230016 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 50 test |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius