FDA UDI
In Commercial Distribution
🇺🇸 United States
ImmunoCard C. difficile GDH
DI: 00840733101793
·
Model: 716050
·
MERIDIAN BIOSCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ImmunoCard C. difficile GDH
- Primary DI
- 00840733101793
- Version / Model
- 716050
- Catalog Number
- 716050
- Company Name
- MERIDIAN BIOSCIENCE, INC.
- Labeler DUNS
- 092815364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-11
- Public Version
- 1
- Public Version Date
- 2020-08-19
- Public Version Status
- New
- Public Device Record Key
- 29220b2c-8ecf-4671-a383-aa2fa2018adf
Device Description
ImmunoCard C. difficile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.
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 |
|---|---|---|---|---|
| MCB | Antigen, C. Difficile | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50832 | Clostridium difficile antigen 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 antigens from Clostridium difficile bacteria [e.g., glutamate dehydrogenase antigen (GDA), toxin A and/or toxin B] 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 | 00840733101793 | GS1 |
Customer Contacts
- Phone
- 513-271-3700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112048 | 000 |