FDA UDI
In Commercial Distribution
🇺🇸 United States
Anti-Lactoferrin ELISA
DI: 00404847436020
·
Model: EIA-3602
·
DRG Instruments Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Anti-Lactoferrin ELISA
- Primary DI
- 00404847436020
- Version / Model
- EIA-3602
- Catalog Number
- EIA-3602
- Company Name
- DRG Instruments Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317134468
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-28
- Public Version
- 1
- Public Version Date
- 2021-08-05
- Public Version Status
- New
- Public Device Record Key
- 2f211124-133b-4158-b23a-2d6f4cf611fd
Device Description
Anti-Lactoferrin ELISA is a test system for the quantitative measurement of IgG class autoantibodies against Lactoferrin in human serum or plasma.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DEG | LACTOFERRIN, ANTIGEN, ANTISERUM, CONTROL | Immunology | 866.5570 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65642 | Lactoferrin anti-neutrophil cytoplasmic antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-neutrophil cytoplasmic antibodies (ANCA) to lactoferrin in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of inflammatory disorders such as rheumatoid vasculitis, ulcerative colitis (UC) and primary sclerosing cholangitis (PSC). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00404847436020 | GS1 |
Customer Contacts
- Phone
- +1(973)564-7555
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius