Hydrocodone 300 Semi-Quantitative Calibrators Set
- Primary DI
- 00850624008162
- Brand
- Hydrocodone 300 Semi-Quantitative Calibrators Set
- Company
- LIN-ZHI INTERNATIONAL, INC.
- Model
- 08239827190
- Catalog number
- 08239827190
- Device description
- HYD 300 Negative Calibrator 0 ng/mL (1 x 5 mL), HYD 300 Low Calibrator 150 ng/mL (1 x 5 mL), HYD 300 Cutoff Calibrator 300 ng/mL (1 x 5 mL), HYD 300 Intermediate Calibrator 500 ng/mL (1 x 5 mL), HYD 300 High Calibrator 800 ng/mL (1 x 5 mL).
- Published
- 2018-04-20
- 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
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| DLJ | Calibrators, Drug Specific |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DLJ | Calibrators, Drug Specific | Clinical Toxicology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00850624008162 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00850624008162 | 00850624008162 | 850624008162 | 0850624008162 |
GMDN Terms
| Term | Definition |
|---|---|
| Opiate/opiate metabolite IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites 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
- 840839190
- 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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