OSOM Strep A 10 Test Kit
- Primary DI
- 00742860100109
- Brand
- OSOM Strep A 10 Test Kit
- Company
- SEKISUI DIAGNOSTICS, LLC
- Model
- 141-10
- Catalog number
- 141-10
- Published
- 2016-09-16
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| GTZ | ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | Microbiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00742860100109 | Primary | GS1 | 0 | |
| 10742860100106 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00742860100109 | 00742860100109 | 742860100109 | 0742860100109 |
| 10742860100106 | 10742860100106 |
GMDN Terms
| Term | Definition |
|---|---|
| Beta-haemolytic Group A Streptococcus antigen IVD, kit, immunochromatographic test (ICT), rapid | A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 966812344
- Device count
- 10
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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