FDA UDI
In Commercial Distribution
🇺🇸 United States
Capture-CMV
DI: 10888234002154
·
Model: 0066216
·
IMMUCOR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Capture-CMV
- Primary DI
- 10888234002154
- Version / Model
- 0066216
- Catalog Number
- 0066216
- Company Name
- IMMUCOR, INC.
- Labeler DUNS
- 061446282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-14
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a74dfbdc-9a50-4b02-a6dc-c9f403fef8e2
Device Description
Capture-CMV is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV is intended to be used in screening of donors or patients for serological evidence of previous infection by CMV. This is the five plate product.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LJO | Antigen, Iha, Cytomegalovirus | Microbiology | 866.3175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49710 | Cytomegalovirus (CMV) antigen IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from cytomegalovirus (CMV) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888234002154 | GS1 |
Customer Contacts
- Phone
- 1-855-466-8267
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K910003 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius