CAROLINA LIQUID CHEMISTRIES CORP.® OP RGT. KIT BL-411A
- Primary DI
- 00817302021561
- Brand
- CAROLINA LIQUID CHEMISTRIES CORP.® OP RGT. KIT BL-411A
- Company
- CAROLINA LIQUID CHEMISTRIES CORPORATION
- Model
- BL411A
- Catalog number
- BL411A
- Device description
- OP (Opiates) 2 x 100 tests
- Published
- 2016-09-01
- 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
Product Codes
| Code | Name |
|---|
| DJG | ENZYME IMMUNOASSAY, OPIATES |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00817302021561 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00817302021561 | 00817302021561 | 817302021561 | 0817302021561 |
GMDN Terms
| Term | Definition |
|---|
| Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen, using an enzyme immunoassay (EIA) method. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
| Total Volume | 8 | Milliliter |
| Total Volume | 20 | Milliliter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Reagent is stable when stored at 2-8° C until expiration date |
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 962385787
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- true
- 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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Other Devices Sharing Product Codes
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