FDA UDI
In Commercial Distribution
🇺🇸 United States
Light Diagnostics™ Varicella- Zoster Virus DFA Kit
DI: 08436037124716
·
Model: 3430
·
EMD Millipore Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Light Diagnostics™ Varicella- Zoster Virus DFA Kit
- Primary DI
- 08436037124716
- Version / Model
- 3430
- Catalog Number
- 3430
- Company Name
- EMD Millipore Corporation
- Labeler DUNS
- 829517072
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- ee110375-845b-4df7-8058-6a20c3ac912d
Device Description
Varicella- Zoster Virus DFA Kit
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| GQX | Antiserum, Cf, Varicella-Zoster | Microbiology | 866.3900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49615 | Varicella-zoster virus (VZV) antigen IVD, kit, direct fluorescent test (DFT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from varicella-zoster virus (VZV) in a clinical specimen, using a direct fluorescent test (DFT). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08436037124716 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K951799 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius