FDA UDI
In Commercial Distribution
🇺🇸 United States
C. DIFFICILE TOXIN ANTITOXIN KIT
DI: 00857031002066
·
Model: T5000
·
TECHLAB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- C. DIFFICILE TOXIN ANTITOXIN KIT
- Primary DI
- 00857031002066
- Version / Model
- T5000
- Company Name
- TECHLAB, INC.
- Labeler DUNS
- 614218634
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-24
- Public Version
- 1
- Public Version Date
- 2020-02-03
- Public Version Status
- New
- Public Device Record Key
- 9c3ef5f9-0d22-4dfd-86f2-a548247c03c0
Device Description
The Clostridium difficile Toxin/Antitoxin Kit is intended for use in conjunction with the tissue culture cytotoxicity assay for the confirmation of Clostridium difficile toxin in patient specimens. The kit includes a toxin control reagent and a specific C. difficile antitoxin for use in a tissue culture assay. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63037 | Clostridium difficile antigen IVD, kit, cell culture assay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative measurement of the cytotoxicity of antigens to Clostridium difficile bacteria [e.g., toxin A and/or toxin B] in a clinical specimen, using a cell culture assay. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857031002066 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K923463 | 000 |