Immunalysis Corporation
- Primary DI
- 00840937110591
- Brand
- Immunalysis Corporation
- Company
- IMMUNALYSIS CORPORATION
- Model
- 240-0480EX
- Device description
- Immunalysis Corporation Ketamine Direct ELISA Export Kit: 5 plate (240-0480EX)
- Published
- 2017-09-29
- 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 |
|---|
| 00840937110591 | Primary | GS1 | 0 | |
Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.
Alternate GTIN / UPC / EAN Codes
| Source identifier | Source length | GTIN-14 normalized | Indicator | UPC-A | EAN-13 | Conversion note |
|---|
| 00840937110591 | 14 | 00840937110591 | 0 | 840937110591 | 0840937110591 | Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion. |
GMDN Terms
| Term | Definition |
|---|
| Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative detection of ketamine and/or ketamine metabolites in a clinical specimen, using an enzyme immunoassay (EIA) method. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 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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