FDA UDI
In Commercial Distribution
🇺🇸 United States
IHC
DI: 00810170551659
·
Model: (BTO) RTU MART-1/Melan-A Melanoma Marker (2x) (A103) Antibody (25mL)
·
Slmp, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IHC
- Primary DI
- 00810170551659
- Version / Model
- (BTO) RTU MART-1/Melan-A Melanoma Marker (2x) (A103) Antibody (25mL)
- Catalog Number
- MM97-2X-25
- Company Name
- Slmp, LLC
- Labeler DUNS
- 118544521
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-06
- Public Version
- 1
- Public Version Date
- 2025-03-14
- Public Version Status
- New
- Public Device Record Key
- 384b47f4-882e-4d41-acc5-e351fe7e320e
Device Description
MART-1/Melan A, (2X) Clone A103, 25mL
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- Yes
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 |
|---|---|---|---|---|
| 57393 | Melan-A/MART-1 peptide IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of Melan-A/MART-1 peptide in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810170551659 | GS1 |