Immunalysis Corporation
- Primary DI
- 00840937105115
- Brand
- Immunalysis Corporation
- Company
- IMMUNALYSIS CORPORATION
- Model
- QS-0500-DP
- Device description
- Immunalysis Corporation Quantisal 0500 Dual Pad
- 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
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840937105115 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00840937105115 | 00840937105115 | 840937105115 | 0840937105115 |
GMDN Terms
| Term | Definition |
|---|
| Drug-testing specimen collection kit IVD | A covered receptacle and other associated materials/tools, available either [non-prescription] over-the-counter and/or to health professionals, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other investigation. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 30 Degrees Celsius | |
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
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