FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Fluorescent ANA Test System
DI: M74900M1211
·
Model: M12 (1)
·
IMMUNO CONCEPTS INC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fluorescent ANA Test System
- Primary DI
- M74900M1211
- Version / Model
- M12 (1)
- Catalog Number
- M12 (1)
- Company Name
- IMMUNO CONCEPTS INC
- Labeler DUNS
- 038271904
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2019-11-11
- Public Version Status
- Update
- Public Device Record Key
- e0d5a224-2f2b-4ccf-ad28-605c74fbc8cb
- Distribution End Date
- 2016-09-30
Device Description
OEM ANA HEp-2 - 1 x 12 well slide
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54808 | Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) 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 | M74900M1211 | HIBCC |