FDA UDI
In Commercial Distribution
🇺🇸 United States
ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay
DI: 05056080501673
·
Model: R2474096
·
REMEL EUROPE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay
- Primary DI
- 05056080501673
- Version / Model
- R2474096
- Company Name
- REMEL EUROPE LIMITED
- Labeler DUNS
- 232600853
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-21
- Public Version
- 1
- Public Version Date
- 2021-07-29
- Public Version Status
- New
- Public Device Record Key
- 564d7db0-c06d-4ba4-9f5a-23e3e4282bea
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
- 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 |
|---|---|---|---|---|
| GMZ | Antigens, All Types, Escherichia Coli | Microbiology | 866.3255 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50923 | Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05056080501673 | GS1 |
Customer Contacts
- Phone
- +4401256694238
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K980507 | 000 |