FDA UDI
In Commercial Distribution
🇺🇸 United States
ELISA RF IgM Test Sytem
DI: 00845533000970
·
Model: 2Z9291M
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ELISA RF IgM Test Sytem
- Primary DI
- 00845533000970
- Version / Model
- 2Z9291M
- Catalog Number
- 2Z9291M
- 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
- 1598503e-7577-4d0f-b1b8-ffe8ef08946a
Device Description
The ZEUS ELISA Rheumatoid Factor (RF) IgM Test System is intended for the qualitative and semi-quantitative detection of RF IgM class antibody in human sera. The test is intended to be used as an aid in the diagnosis of rheumatoid arthritis and 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 |
|---|---|---|---|---|
| 55107 | Rheumatoid factor 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 rheumatoid factor immunoglobulins in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533000970 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius