FDA UDI
In Commercial Distribution
🇺🇸 United States
ImmunoFLOW Negative Control Mycoplasma IgM
DI: 00613745000145
·
Model: 800-3921
·
GenBio
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ImmunoFLOW Negative Control Mycoplasma IgM
- Primary DI
- 00613745000145
- Version / Model
- 800-3921
- Catalog Number
- 3921
- Company Name
- GenBio
- Labeler DUNS
- 940425333
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-19
- Public Version
- 1
- Public Version Date
- 2026-04-27
- Public Version Status
- New
- Public Device Record Key
- 64ae7914-d1db-477c-ad72-0d51641f887f
Device Description
Mycoplasma IgM Negative Control contains human serum without reactivity to Mycoplasma pneumoniae complement–fixing antigen and is used in conjunction with the appropriate ImmunoFLOW Assay Test System.
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 |
|---|---|---|---|---|
| 51202 | Mycoplasma pneumoniae immunoglobulin M (IgM) 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 M (IgM) 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 | 00613745000145 | GS1 |
Customer Contacts
- Phone
- 858-592-9300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 0.5 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius