FDA UDI
In Commercial Distribution
🇺🇸 United States
InTray® DM
DI: B08820630
·
Model: 2063
·
BIO-MED DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- InTray® DM
- Primary DI
- B08820630
- Version / Model
- 2063
- Catalog Number
- 22-063-000
- Company Name
- BIO-MED DIAGNOSTICS, INC.
- Labeler DUNS
- 605213545
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-13
- Public Version
- 2
- Public Version Date
- 2019-07-18
- Public Version Status
- Update
- Public Device Record Key
- 5fe6a40a-c01e-4abc-bec4-5aa0d95ac6a4
Device Description
An enriched dermatophyte medium used in the detection of dermatophytes from clinical specimens.
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 |
|---|---|---|---|---|---|---|
| Primary | B08820630 | HIBCC | ||||
| Package | B08820634 | HIBCC | Box | 20 | In Commercial Distribution | |
| Package | B08820632 | HIBCC | Box | 5 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius