FDA UDI
In Commercial Distribution
🇺🇸 United States
InTray® COLOREX Yeast
DI: B08811130
·
Model: 1113
·
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® COLOREX Yeast
- Primary DI
- B08811130
- Version / Model
- 1113
- Catalog Number
- 21-113-001
- Company Name
- BIO-MED DIAGNOSTICS, INC.
- Labeler DUNS
- 605213545
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-13
- Public Version
- 1
- Public Version Date
- 2018-10-15
- Public Version Status
- New
- Public Device Record Key
- 778b0a3a-2386-49bf-83d5-86d081c425b8
Device Description
For isolation and differentiation of major clinically significant Candida species. Suitable for direct streaking of samples from skin,sputum, urine or genitourinary swabs.
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 |
|---|---|---|---|---|
| 30666 | Multiple Candida/yeast 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 Candida and/or yeast 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 | B08811134 | HIBCC | Box | 20 | In Commercial Distribution | |
| Primary | B08811130 | HIBCC | ||||
| Package | B08811132 | HIBCC | Box | 5 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius