FDA UDI
In Commercial Distribution
🇺🇸 United States
Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay
DI: M445MCCCGDFA750
·
Model: MCC-C/G-DFA 75
·
MEDICAL CHEMICAL CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay
- Primary DI
- M445MCCCGDFA750
- Version / Model
- MCC-C/G-DFA 75
- Catalog Number
- MCC-C/G-DFA 75
- Company Name
- MEDICAL CHEMICAL CORPORATION
- Labeler DUNS
- 008496861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 06f6a366-1c84-4c1a-a5f1-6c06dc00be0b
Device Description
The Para-Tect Cryptosporidium/Giardia kit is intended to detect Cryptosporidium oocysts and Giardia cysts in human stool by direct immunofluorescence microscopy. This kit contains enough reagents for 75 tests.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| MHI | Giardia Spp. | Microbiology | 866.3220 | 2 |
| MHJ | Cryptosporidium Spp. | Microbiology | 866.3220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47357 | Multiple faecal parasite antigen IVD, kit, direct fluorescent test (DFT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple faecal parasite antigens (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen, using a direct fluorescent test (DFT). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M445MCCCGDFA750 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K024113 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do Not Freeze
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius