IFA CMV IgM Test System
- Primary DI
- 00845533001540
- Brand
- IFA CMV IgM Test System
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- FA9001M
- Catalog number
- FA9001M
- Device description
- The ZEUS IFA Cytomegalovirus (CMV) IgM Test System is designed for qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum. The Test System is intended to be used to evaluate serologic evidence of primary or reactivated infection with CMV and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00845533001540 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533001540 | 00845533001540 | 845533001540 | 0845533001540 |
GMDN Terms
| Term | Definition |
|---|---|
| Cytomegalovirus (CMV) 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 cytomegalovirus (CMV) in a clinical specimen, using a fluorescent immunoassay method. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 080953946
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00845533003551 | Legionella pneumophila (Group 1-6) | FA15001 | FA15001 | 2026-05-26 |
| 00845533003568 | Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG | FA9151G | FA9151G | 2026-05-26 |
| 00845533003575 | Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM | FA9151M | FA9151M | 2026-05-26 |
| 00845533003087 | Anti-M. pneumoniae IgM | Q3Z17601MB | Q3Z17601MB | 2026-03-12 |
| 00845533003094 | Anti-VZV IgM | 9Z9331MB | 9Z9331MB | 2026-03-12 |
| 00845533003063 | Alegria Flash ENA Screen | CL28051 | CL28051 | 2026-02-19 |
| 00845533003070 | Alegria Flash ENA Screen Control Kit | CL28051CK | CL28051CK | 2026-02-19 |
| 00845533002882 | Cardiac Muscle (Rat) | 5448RL | 5448RL | 2026-02-18 |
| 00845533002899 | Adrenal Cortex (Primate) | 6448L | 6448L | 2026-02-18 |
| 00845533002905 | Ovary (Primate) | 6648L | 6648L | 2026-02-18 |
| 00845533002912 | Testes (Primate) | 6748L | 6748L | 2026-02-18 |
| 00845533002929 | Mumps Virus IgG | I-MUV01G | I-MUV01G | 2026-02-18 |
| 00845533002936 | NTx Urine | NTx9006 | 2026-02-18 | |
| 00845533002943 | NTx Serum | NTx9021 | NTx9021 | 2026-02-18 |
| 00845533002950 | Anti-Borrelia VlsE1/pepC10 IgG/IgM | PF-SM3Z9661 | PF-SM3Z9661 | 2026-02-18 |
| 00845533002967 | ANA Screen | 2Z29001G | 2Z29001G | 2026-02-18 |
| 00845533002974 | ANA Screen | SM2Z29001G | SM2Z29001G | 2026-02-18 |
| 00845533002981 | ANCA Screen | 2Z9681G | 2Z9681G | 2026-02-18 |
| 00845533002998 | ANCA Screen | SM2Z9681G | SM2Z9681G | 2026-02-18 |
| 00845533003001 | Anti-Cardiolipin IgA | 2Z51051A | 2Z51051A | 2026-02-18 |