N/A
Basic Information
- Brand Name
- N/A
- Primary DI
- 00816576025572
- Version / Model
- G261
- Catalog Number
- G261
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-05-19
- Public Version
- 1
- Public Version Date
- 2020-05-27
- Public Version Status
- New
- Public Device Record Key
- 15c49928-bc7b-4eab-a6a4-6662016da48e
Device Description
Leeds Acinetobacter Medium, 15x100mm Plate, 18ml. Leeds Acinetobacter Medium is a selective and differential medium intended for use as a plating technique to obtain a pure culture of Acinetobacter. The test is performed with a mixed population of microorganisms from a laboratory sample. Leeds Acinetobacter Medium is not intended for use in the identification of colonization with Acinetobacter to aid in the prevention and control of such bacteria in healthcare settings. Leeds Acinetobacter Medium is not intended to diagnose Acinetobacter infections, guide or monitor treatment for infections, or provide susceptibility results to antibiotics for which any strains of Acinetobacter are resistant. Sub-culturing is necessary for microorganism identification, susceptibility testing, and epidemiological typing.
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 |
|---|---|---|---|---|
| 58585 | Differential/selective agar culture medium IVD | An agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00816576025565 | GS1 | ||||
| Primary | 00816576025572 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius