FDA UDI
In Commercial Distribution
🇺🇸 United States
LT Blood Cross Matching Card
DI: 06974621793143
·
Model: BCM-6
·
Zhuhai Longtime Biological Technology Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LT Blood Cross Matching Card
- Primary DI
- 06974621793143
- Version / Model
- BCM-6
- Company Name
- Zhuhai Longtime Biological Technology Co., Ltd
- Labeler DUNS
- 708328288
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-01
- Public Version
- 1
- Public Version Date
- 2023-08-09
- Public Version Status
- New
- Public Device Record Key
- 2e3aeb15-7a9c-4c94-b608-fa5bf512ae17
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSY | Boxes, View, Blood Grouping | Hematology | 864.9185 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46949 | Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination | A collection of immunoglobulins capable of binding to individual classes of human immunoglobulin and/or complement components fixed to red blood cell antigens, and intended to be used together in testing a clinical specimen to detect red blood cell sensitization by specific molecules, using an agglutination technique. The specific molecules intended to be detected may include immunoglobulin A (IgA), immunoglobulin G (IgG), immunoglobulin M (IgM), C3c, and/or C3d. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974621793143 | GS1 |