FDA UDI
In Commercial Distribution
🇺🇸 United States
Mono Mo A-Rb Immunoglobulins Cl MR12/53
DI: 05700572005049
·
Model: M0737
·
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mono Mo A-Rb Immunoglobulins Cl MR12/53
- Primary DI
- 05700572005049
- Version / Model
- M0737
- Company Name
- AGILENT TECHNOLOGIES SINGAPORE PTE LTD
- Labeler DUNS
- 894671143
- 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
- 9a31e89b-8ee6-4113-b59a-ce79bf195c8b
Device Description
Monoclonal Mouse Anti-Rabbit Immunoglobulins Clone MR12/53
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 |
|---|---|---|---|---|
| 57780 | Immunohistochemistry conjugated secondary antibody IVD | One or multiple conjugated immunoglobulins capable of binding to specific antigenic determinants, and intended to be used for the detection of primary antibodies bound to specific cell markers when testing biological tissues or clinical specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700572005049 | GS1 |
Customer Contacts
- Phone
- +4544859500
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius