FDA UDI
In Commercial Distribution
🇺🇸 United States
ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST
DI: 00613745031200
·
Model: 800-3120
·
GenBio
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST
- Primary DI
- 00613745031200
- Version / Model
- 800-3120
- Catalog Number
- 3120
- Company Name
- GenBio
- Labeler DUNS
- 940425333
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-29
- Public Version
- 2
- Public Version Date
- 2026-04-20
- Public Version Status
- Update
- Public Device Record Key
- e2a80941-1921-404a-b3b1-8e54e450a065
Device Description
ImmunoWELL Mycoplasma Pneumoniae Antibody (IgG) Test is a semi–quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The test may be used to evaluate paired sera for the presence of seroconversion and a significant increase in specific IgG and in the diagnosis of Mycoplasma pneumoniae infection in the adult population.
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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | Microbiology | 866.3375 | 1 |
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 | 00613745031200 | GS1 |
Customer Contacts
- Phone
- 858-592-9300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 96 tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius