FDA UDI
In Commercial Distribution
🇺🇸 United States
Poly Rb A-Hu Lysozyme EC 3.2.1.17
DI: 05700572000686
·
Model: A0099
·
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Poly Rb A-Hu Lysozyme EC 3.2.1.17
- Primary DI
- 05700572000686
- Version / Model
- A0099
- 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
- 060f3dd3-eeaf-4104-b78b-0ca214536403
Device Description
Polyclonal Rabbit Anti-Human Lysozyme EC 3.2.1.17
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 |
|---|---|---|---|---|
| JMR | IMMUNOCHEMICAL, LYSOZYME (MURAMIDASE) | Clinical Chemistry | 862.1490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57364 | Lysozyme (muramidase) 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 the bacteriolytic enzyme lysozyme (muramidase) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700572000686 | GS1 |
Customer Contacts
- Phone
- +4544859500
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 2 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius