FDA UDI
In Commercial Distribution
🇺🇸 United States
AIMSTEP MONO
DI: 00695684770259
·
Model: 77025
·
GERMAINE LABORATORIES, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- AIMSTEP MONO
- Primary DI
- 00695684770259
- Version / Model
- 77025
- Company Name
- GERMAINE LABORATORIES, INC
- Labeler DUNS
- 176458115
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-04-27
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- e3fa631f-488a-4ffc-ac23-77206b4b5bc1
Device Description
A rapid cassette test for the qualitative detection of Infectious Mononucleosis (IM) heterophile antibodies in serum, plasma, or whole blood.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | Immunology | 866.5640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60620 | Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative/quantitative detection of immunoglobulin M (IgM) antibodies to the early antigen (EA) of Epstein-Barr virus (EBV) in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00695684770259 | GS1 | ||||
| Unit of Use | 00695684770251 | GS1 |