FDA UDI
In Commercial Distribution
🇺🇸 United States
InTray® PDA
DI: B08812930
·
Model: 1293
·
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® PDA
- Primary DI
- B08812930
- Version / Model
- 1293
- Catalog Number
- 21-293-001
- Company Name
- BIO-MED DIAGNOSTICS, INC.
- Labeler DUNS
- 605213545
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-12
- Public Version
- 1
- Public Version Date
- 2018-10-15
- Public Version Status
- New
- Public Device Record Key
- 1f2cc956-0882-4a79-9092-8846d1e2f328
Device Description
Recommended by the American Public Health Association for plate counts of yeasts and molds in the examination of foods and dairy products, it is also used for maintenance, cultivation and sporulation of stock cultures of various dermatophytes and for differentiation of atypical varieties of dermatophytes by pigment production.
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 |
|---|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-Differential | Microbiology | 866.2300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58653 | Potato-dextrose fungal agar culture medium IVD | A selective and/or differential agar culture medium intended to be used for the growth and isolation of yeasts and moulds from a clinical specimen. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B08812934 | HIBCC | Box | 20 | In Commercial Distribution | |
| Primary | B08812930 | HIBCC | ||||
| Package | B08812932 | HIBCC | Box | 5 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius