Immunalysis Corporation
- Primary DI
- 00840937110409
- Brand
- Immunalysis Corporation
- Company
- IMMUNALYSIS CORPORATION
- Model
- 3010-5
- Device description
- Immunalysis Corporation Ethyl Alcohol Urine Control Set
- Published
- 2017-09-07
- 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
Product Codes
| Code | Name |
|---|---|
| DKC | Alcohol control materials |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DKC | Alcohol Control Materials | Clinical Toxicology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00840937110409 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00840937110409 | 00840937110409 | 840937110409 | 0840937110409 |
GMDN Terms
| Term | Definition |
|---|---|
| Ethyl glucuronide (EtG) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of ethyl glucuronide (EtG), a metabolite of ethanol alcohol (ETOH), in a clinical specimen. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
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 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00811727017420 | Pointe Ethyl Alcohol Level 1 Control (50 mg/dL) | POINTE SCIENTIFIC, INC. | DKC | 2020-09-25 |
| 00811727017437 | Pointe Ethyl Alcohol Level 2 Control (300 mg/dL) | POINTE SCIENTIFIC, INC. | DKC | 2020-09-25 |
| 04250317535771 | Urine Control | Chromsystems Instruments + Chemicals GmbH | DKC | 2020-08-06 |
| 04250317535788 | Urine Control | Chromsystems Instruments + Chemicals GmbH | DKC | 2020-08-06 |
| 04250317535795 | Urine Control | Chromsystems Instruments + Chemicals GmbH | DKC | 2020-08-06 |
| 04250317502209 | Serum Control | Chromsystems Instruments + Chemicals GmbH | DKC | 2020-07-30 |
| 04250317502223 | Serum Control | Chromsystems Instruments + Chemicals GmbH | DKC | 2020-07-30 |
| 00817238011568 | WHOLE BLOOD ETHANOL CONTROL LEVEL1 | CLINIQA CORPORATION | DKC | 2018-08-23 |
| 00817238011575 | WHOLE BLOOD ETHANOL CONTROL LEVEL 2 | CLINIQA CORPORATION | DKC | 2018-08-23 |
| 00380740135379 | Alinity | ABBOTT LABORATORIES | DKC | 2018-07-11 |
| 00884883001015 | DRI 50 mg/dL Alcohol Control | Microgenics Corporation | DKC | 2017-10-30 |
| 00884883001039 | DRI 300 mg/dL Alcohol Control | Microgenics Corporation | DKC | 2017-10-30 |
| 00840937110683 | Immunalysis Corporation | IMMUNALYSIS CORPORATION | DKC | 2017-10-24 |
| 00884883005129 | DRI Negative Alcohol Calibrator | Microgenics Corporation | DKC | 2016-09-12 |
| 00884883005198 | DRI 100 mg/dL Alcohol Calibrator | Microgenics Corporation | DKC | 2016-09-12 |
| 00884883011540 | DRI 100 mg/dL Alcohol Calibrator | Microgenics Corporation | DKC | 2016-09-12 |
| 00884883011564 | DRI Negative Alcohol Calibrator | Microgenics Corporation | DKC | 2016-09-12 |
| 15099590222710 | Synchron | Beckman Coulter, Inc. | DKC | 2016-08-24 |
| 15099590222727 | Synchron | Beckman Coulter, Inc. | DKC | 2016-08-24 |
| 15099590222734 | Synchron | Beckman Coulter, Inc. | DKC | 2016-08-24 |
| B07602240 | Ethyl Alcohol DAU Control, Level 1 Control | LIN-ZHI INTERNATIONAL, INC. | DKC | 2016-07-05 |
| B07602250 | Ethyl Alcohol DAU Control, Level 2 Control | LIN-ZHI INTERNATIONAL, INC. | DKC | 2016-07-05 |
| 00380740005528 | ARCHITECT | ABBOTT LABORATORIES | DKC | 2016-06-06 |