FDA UDI
In Commercial Distribution
🇺🇸 United States
CLED Agar (Legacy 7122)
DI: 00860003684696
·
Model: 0
·
NEOGEN CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CLED Agar (Legacy 7122)
- Primary DI
- 00860003684696
- Version / Model
- 0
- Catalog Number
- NCM0256
- Company Name
- NEOGEN CORPORATION
- Labeler DUNS
- 069550929
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-08
- Public Version
- 1
- Public Version Date
- 2022-04-18
- Public Version Status
- New
- Public Device Record Key
- d9cbc8f4-1e31-4620-a76d-cf3360c152c3
Device Description
Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enumeration of microorganisms in urine.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | Microbiology | 866.2320 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00860003684696 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius