FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Light Diagnostics ™ Mouse Anti-Rabies Monoclonal Antibody; Clone Name C4-62-15-2
DI: 04053252662829
·
Model: MAB8716
·
EMD Millipore Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Light Diagnostics ™ Mouse Anti-Rabies Monoclonal Antibody; Clone Name C4-62-15-2
- Primary DI
- 04053252662829
- Version / Model
- MAB8716
- Catalog Number
- MAB8716
- Company Name
- EMD Millipore Corporation
- Labeler DUNS
- 829517072
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 2
- Public Version Date
- 2023-08-25
- Public Version Status
- Update
- Public Device Record Key
- a0bc2e16-2a61-45f8-93ac-448956e7dc40
- Distribution End Date
- 2023-04-30
Device Description
Mouse Anti-Rabies Monoclonal Antibody; Clone Name C4-62-15-2
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 |
|---|---|---|---|---|
| MVU | Reagents, Specific, Analyte | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50182 | Rabies virus antigen IVD, antibody | One or multiple immunoglobulins with the capability of binding to specific antigenic determinants intended to be used for the qualitative and/or quantitative detection of antigens from Rabies virus in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04053252662829 | GS1 |
Customer Contacts
- Phone
- 1 (951) 676-8080
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius