FDA UDI
In Commercial Distribution
🇺🇸 United States
ZORBA IgG Removal Reagent
DI: 00845533001717
·
Model: FA003G
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZORBA IgG Removal Reagent
- Primary DI
- 00845533001717
- Version / Model
- FA003G
- Catalog Number
- FA003G
- Company Name
- ZEUS SCIENTIFIC, INC.
- Labeler DUNS
- 080953946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- da5ce6c7-0aa8-423a-90bb-85431d36d052
Device Description
Zorba® IgG Removal Reagent is designed to functionally remove potentially interfering immunoglobulin G (IgG) antibodies from human serum prior to testing for IgM. The product is for In Vitro diagnostic use.
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
- No
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43805 | Immunoglobulin removal reagent IVD | A substance or reactant intended to be used alone or in combination with other IVDs for the removal, adsorption, absorption, or inactivation of non-specific immunoglobulins and/or rheumatoid factor antibodies present in a clinical specimen, to prevent interference when testing for other specific classes of immunoglobulin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533001717 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius