FDA UDI
In Commercial Distribution
🇺🇸 United States
Human Herpesvirus 6 (HHV 6) IgM
DI: 00845533002042
·
Model: I-HV601M
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Human Herpesvirus 6 (HHV 6) IgM
- Primary DI
- 00845533002042
- Version / Model
- I-HV601M
- Catalog Number
- I-HV601M
- Company Name
- ZEUS SCIENTIFIC, INC.
- Labeler DUNS
- 080953946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-07
- Public Version
- 1
- Public Version Date
- 2025-11-17
- Public Version Status
- New
- Public Device Record Key
- 97692724-8057-4879-9923-a4309e5c9fc0
Device Description
The Indirect Fluorescence Assay (IFA) for Human Herpesvirus 6 (HHV6) IgM Antibody is intended for the qualitative and semi-quantitative detection of IgM (Immunoglobulin M) antibody to HHV6 in human serum or plasma. Detection of HHV6 IgM antibody in humans can be used as an aid in the diagnosis of primary infection with this virus.
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 |
|---|---|---|---|---|
| 49755 | Human herpesvirus 6 (HHV6) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Human herpesvirus 6 (HHV6) in a clinical specimen, using a fluorescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533002042 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius