FDA UDI
In Commercial Distribution
🇺🇸 United States
InTray DM-FungID
DI: B08815930
·
Model: 1593
·
BIO-MED DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- InTray DM-FungID
- Primary DI
- B08815930
- Version / Model
- 1593
- Catalog Number
- 21-593-001
- Company Name
- BIO-MED DIAGNOSTICS, INC.
- Labeler DUNS
- 605213545
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-10
- Public Version
- 1
- Public Version Date
- 2020-02-18
- Public Version Status
- New
- Public Device Record Key
- 4095c25a-987f-4304-bff3-b0833b2a3606
Device Description
InTray® DM-FungID™ is an enriched dermatophyte medium used to aid in the detection of dermatophytes from clinical specimens with mixed micobiota.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JSI | Culture Media, Selective And Differential | Microbiology | 866.2360 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33358 | Multiple dermatophyte species culture isolate identification IVD, kit | A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of dermatophyte or other fungi isolated by culture from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B08815934 | HIBCC | Box | 20 | In Commercial Distribution | |
| Primary | B08815930 | HIBCC | ||||
| Package | B08815932 | HIBCC | box | 5 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius