FDA UDI
In Commercial Distribution
🇺🇸 United States
Dermatophyte and C. albicans Real Time PCR kit
DI: 05713106994627
·
Model: 99462
·
Ssi Diagnostica A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dermatophyte and C. albicans Real Time PCR kit
- Primary DI
- 05713106994627
- Version / Model
- 99462
- Catalog Number
- 99462
- Company Name
- Ssi Diagnostica A/S
- Labeler DUNS
- 305684449
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-25
- Public Version
- 1
- Public Version Date
- 2022-12-05
- Public Version Status
- New
- Public Device Record Key
- e36ef7e7-bad7-4b7c-9c7e-f66430c346e3
Device Description
Intended use The Dermatophyte and C. albicans Real Time PCR Kit is an in vitro diagnostic kit for the quantitative detection of general dermatophytes (pan-dermatophytes), Trichophyton (T.) rubrum and Candida (C.) albicans in nail, skin, and hair specimens.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| JSR | Kit, Identification, Dermatophyte | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62577 | Multiple dermatophyte species nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple dermatophyte species, which may include M. canis, M. audouinii, T. rubrum and T. violaceum in a clinical specimen, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05713106994627 | GS1 |
Customer Contacts
- Phone
- +4548299100
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Stored at a dark place at -20 Degrees Celsius