FDA UDI
In Commercial Distribution
🇺🇸 United States
Sure-Vue
DI: 00613647000304
·
Model: 23-200-277
·
FISHER SCIENTIFIC COMPANY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
Basic Information
- Brand Name
- Sure-Vue
- Primary DI
- 00613647000304
- Version / Model
- 23-200-277
- Catalog Number
- 23200277
- Company Name
- FISHER SCIENTIFIC COMPANY L.L.C.
- Labeler DUNS
- 004321519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 7ea3a34d-2574-46d7-ab0d-2cb283b13ecc
Device Description
Sure-Vue Signature Cryptosporidium and Giardia Test Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47358 | Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple faecal parasites (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20613647000308 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 00613647000304 | GS1 | ||||
| Unit of Use | 10613647000301 | GS1 |
Customer Contacts
- Phone
- +018007667000
- [email protected]