FDA UDI
In Commercial Distribution
🇺🇸 United States
InTray® Brilliant Green
DI: B08814630
·
Model: 1463
·
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® Brilliant Green
- Primary DI
- B08814630
- Version / Model
- 1463
- Catalog Number
- 21-463-001
- 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
- 201cda9d-ddfc-4d89-9688-709cbbd83e2c
Device Description
Highly selective medium for the isolation of Salmonella other than S. typhi from feces and other materials.
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 |
|---|---|---|---|---|
| 58635 | MLCB Salmonella species agar culture medium IVD | A selective and/or differential agar culture medium containing mannitol, lysine, crystal violet, and brilliant green (MLCB), intended to be used for the growth and isolation of Salmonella species other than S. typhi and S. paratyphi from a clinical specimen. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B08814634 | HIBCC | Box | 20 | In Commercial Distribution | |
| Primary | B08814630 | HIBCC | ||||
| Package | B08814632 | HIBCC | Box | 5 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius