LABType™ CWD Class I A Locus Typing Test
- Primary DI
- 00814695022632
- Brand
- LABType™ CWD Class I A Locus Typing Test
- Company
- ONE LAMBDA, INC.
- Model
- N/A
- Catalog number
- RSSOW1A
- Device description
- DNA typing of HLA Class I or Class II alleles.
- Published
- 2017-03-17
- 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
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00814695022632 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00814695022632 | 00814695022632 | 814695022632 | 0814695022632 |
GMDN Terms
| Term | Definition |
|---|
| HLA class I & II antigen tissue typing IVD, kit, multiplex | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class I and II antigens in a clinical specimen, using a multiplex method. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | -80 Degrees Celsius | -20 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 118289289
- 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
- true
- 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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