FDA UDI
Not in Commercial Distribution
🇺🇸 United States
EZ-SALMONELLA One-Step Salmonella species Rapid Test
DI: 08305901007151
·
Model: 1007-15
·
BIOMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EZ-SALMONELLA One-Step Salmonella species Rapid Test
- Primary DI
- 08305901007151
- Version / Model
- 1007-15
- Company Name
- BIOMERICA, INC.
- Labeler DUNS
- 067647321
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-08
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- bf883c35-7387-434c-b595-b690439c6685
- Distribution End Date
- 2020-07-01
Device Description
The Biomerica Salmonella test is a lateral flow immunoassay for the rapid determination of the presence of Salmonella species in human stool samples. The test is intended for professional use only.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| GRM | Antisera, All Groups, Salmonella Spp. | Microbiology | 866.3550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51512 | Multiple Salmonella species 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 species of Salmonella bacteria 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 |
|---|---|---|---|---|---|---|
| Primary | 08305901007151 | GS1 |
Customer Contacts
- Phone
- +1 949 645 2111
- [email protected]