FDA UDI
In Commercial Distribution
🇺🇸 United States
ELISA M. pneumoniae IgG Smart Kit Test System
DI: 00845533000925
·
Model: SM3Z17601G
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELISA M. pneumoniae IgG Smart Kit Test System
- Primary DI
- 00845533000925
- Version / Model
- SM3Z17601G
- Catalog Number
- SM3Z17601G
- 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
- c33db72c-fff1-4ab0-a4a9-00ed828f747e
Device Description
The ZEUS ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. The test may aid in the determination of the patient’s serological status, or may aid in the diagnosis of disease associated with Mycoplasma pneumoniae. Potential cross-reactivity with M. genitalium has not been assessed, nor were studies performed on very young and/or elderly patients.
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 |
|---|---|---|---|---|
| 51207 | Mycoplasma pneumoniae immunoglobulin G (IgG) 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 immunoglobulin G (IgG) antibodies to Mycoplasma pneumoniae bacteria 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 | 00845533000925 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius