Immunalysis Corporation
- Primary DI
- 00840937105122
- Brand
- Immunalysis Corporation
- Company
- IMMUNALYSIS CORPORATION
- Model
- RA-1000
- Device description
- Immunalysis Corporation Alcohol Strips 1000
- Published
- 2016-08-31
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00840937105122 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00840937105122 | 00840937105122 | 840937105122 | 0840937105122 |
GMDN Terms
| Term | Definition |
|---|---|
| Ethanol (ETOH) IVD, kit, colorimetric, rapid | A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of ethyl alcohol (ETOH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a colorimetric method. This test is commonly used in the laboratory or in point-of-care analyses to assess for alcohol intoxication and in the management of alcoholism. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 080589004
- Device count
- 1
- 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
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00840937103265 | Immunalysis Corporation | 10047-10 | 10047-10 | 2023-10-26 |
| 00840937103272 | Immunalysis Corporation | 10048-10 | 10048-10 | 2023-10-26 |
| 00840937103289 | Immunalysis Corporation | 10049-10 | 10049-10 | 2023-10-26 |
| 00840937103296 | Immunalysis Corporation | 10050-10 | 10050-10 | 2023-10-26 |
| 00840937103302 | Immunalysis Corporation | 3018-10 | 3018-10 | 2023-10-26 |
| 00840937111864 | Immunalysis Corporation | 647OF-0100 | 647OF-0100 | 2023-10-25 |
| 00840937111871 | Immunalysis Corporation | 647OF-0500 | 647OF-0500 | 2023-10-25 |
| 00840937112007 | Immunalysis Corporation | 609OF-0100 | 609OF-0100 | 2023-10-25 |
| 00840937112014 | Immunalysis Corporation | 609OF-0500 | 609OF-0500 | 2023-10-25 |
| 00840937103142 | Immunalysis | QS-76501 | QS-76501 | 2023-03-29 |
| 00840937112120 | SEFRIA™ | 612OF-0100 | 2021-09-30 | |
| 00840937112137 | SEFRIA™ | 612OF-0500 | 2021-09-30 | |
| 00840937112076 | Immunalysis Corporation | 3017-10 | 3017-10 | 2021-02-05 |
| 00840937112083 | Immunalysis Corporation | 10054-10 | 10054-10 | 2021-02-05 |
| 00840937112090 | Immunalysis Corporation | 10053-10 | 10053-10 | 2021-02-05 |
| 00840937112106 | Immunalysis Corporation | 10052-10 | 10052-10 | 2021-02-05 |
| 00840937112113 | Immunalysis Corporation | 10051-10 | 10051-10 | 2021-02-05 |
| 00840937112175 | Immunalysis Corporation | 324OF-0100 | 324OF-0100 | 2021-02-01 |
| 00840937112182 | Immunalysis Corporation | 324OF-0500 | 324OF-0500 | 2021-02-01 |
| 00840937112052 | Quantisal | QSI-POUCH | QSI-POUCH | 2020-10-06 |