FDA UDI
In Commercial Distribution
🇺🇸 United States
Fungal Immunodiffusion Plates - 4 Series
DI: 00840733101397
·
Model: 101009
·
MERIDIAN BIOSCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Fungal Immunodiffusion Plates - 4 Series
- Primary DI
- 00840733101397
- Version / Model
- 101009
- Catalog Number
- 101009
- Company Name
- MERIDIAN BIOSCIENCE, INC.
- Labeler DUNS
- 092815364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-21
- Public Version
- 2
- Public Version Date
- 2026-03-25
- Public Version Status
- Update
- Public Device Record Key
- b2a5540c-9b38-4707-9227-7f8c5188bf7f
Device Description
For the detection of circulating antibody to common systemic pathogens.
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 |
|---|---|---|---|---|
| JZQ | Plates And Equipment, Radial Immunodiffusion | Immunology | 866.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51969 | Multiple fungi exoantigen IVD, kit, precipitation/immunodiffusion | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple exoantigens from fungal species, which may include Histoplasma capsulatum, Blastomyces dermatitidis and/or Coccidioides immitis in a clinical specimen, using a precipitation/immunodiffusion method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840733101397 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K792699 | 000 |