FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Light Diagnostics ™ Coxsackievirus B Blend Monoclonal Antibodies
DI: 04053252734557
·
Model: 3303
·
EMD Millipore Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Light Diagnostics ™ Coxsackievirus B Blend Monoclonal Antibodies
- Primary DI
- 04053252734557
- Version / Model
- 3303
- Catalog Number
- 3303
- Company Name
- EMD Millipore Corporation
- Labeler DUNS
- 829517072
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-29
- Public Version
- 2
- Public Version Date
- 2023-08-25
- Public Version Status
- Update
- Public Device Record Key
- 3220eb85-d562-443a-8429-5d81735c4d21
- Distribution End Date
- 2023-04-30
Device Description
Coxsackievirus B Blend Monoclonal Antibodies
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| GNM | Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 | Microbiology | 866.3145 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48561 | Coxsackie A/B virus 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 multiple Coxsackie virus antigens from group A and B in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04053252734557 | GS1 |
Customer Contacts
- Phone
- 1 (951) 676-8080
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K940471 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius