FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00810047420484
·
Model: 2303
·
Scientific Device Laboratory, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00810047420484
- Version / Model
- 2303
- Company Name
- Scientific Device Laboratory, Inc.
- Labeler DUNS
- 115927956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-31
- Public Version
- 1
- Public Version Date
- 2023-02-08
- Public Version Status
- New
- Public Device Record Key
- 4b0b4d10-fbb3-471a-a1a7-d9cdad03e9e6
Device Description
McFarland 3.0 - Not sold individually - Min quantity order of 10 [min order 10]
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 |
|---|---|---|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62854 | McFarland standard IVD | A standard solution intended to be used as a reference in the estimation of the number of bacteria in a suspension based on the turbidity, compared to that of the McFarland standard. It consists of specified volumes of barium chloride and sulphuric acid. The standard is typically used to adjust the inoculum in microbial assays (e.g., microbial susceptibility and microbial identification) where a standardized inoculum is required. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810047420484 | GS1 |