FDA UDI
In Commercial Distribution
🇺🇸 United States
ELISA HSV-2 IgG Smart Kit Test System
DI: 00845533000758
·
Model: SM9Z9751G
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELISA HSV-2 IgG Smart Kit Test System
- Primary DI
- 00845533000758
- Version / Model
- SM9Z9751G
- Catalog Number
- SM9Z9751G
- Company Name
- ZEUS SCIENTIFIC, INC.
- Labeler DUNS
- 080953946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 8a22a23f-38e8-420f-b361-5361da62713f
Device Description
The ZEUS ELISA Herpes Simplex Virus-2 (HSV-2) IgG Test System is an enzyme-linked immunosorbent assays (ELISA) for the qualitative detection of IgG class antibodies to Herpes Simplex Virus (HSV) in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross-reactivity of shared antigens, both tests (HSV-1 and HSV-2 ELISAs) must be run in parallel on the same sample to fully evaluate patient sera. This test is for In Vitro diagnostic use.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49595 | Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to herpes simplex virus 2 (HSV2) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533000758 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius