FDA UDI
In Commercial Distribution
🇺🇸 United States
Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum
DI: 10888234001546
·
Model: 0066902
·
IMMUCOR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum
- Primary DI
- 10888234001546
- Version / Model
- 0066902
- Catalog Number
- 0066902
- Company Name
- IMMUCOR, INC.
- Labeler DUNS
- 061446282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-03
- Public Version
- 1
- Public Version Date
- 2022-09-12
- Public Version Status
- New
- Public Device Record Key
- 33b72fcc-5af1-497a-b068-bd48fe5014b6
Device Description
Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture-R Solid Phase Assays, including Capture-R Select, Capture-R Ready-Screen and Capture-R Ready-ID. Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells and sodium azide added as a preservative. Capture-R Negative Control Serum contains no antibodies to red blood cells; sodium azide is added as a preservative.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| KSS | Supplies, Blood-Bank | Hematology | 864.9050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41353 | Total immunoglobulin G (IgG total) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total immunoglobulin G (IgG total) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888234001546 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 1 – 10 Degrees Celsius