FDA UDI
In Commercial Distribution
🇺🇸 United States
IMMCO DIAGNOSTICS
DI: 00845714003707
·
Model: 2216
·
IMMCO DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IMMCO DIAGNOSTICS
- Primary DI
- 00845714003707
- Version / Model
- 2216
- Catalog Number
- 2216
- Company Name
- IMMCO DIAGNOSTICS, INC.
- Labeler DUNS
- 079935300
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-16
- Public Version
- 4
- Public Version Date
- 2019-01-08
- Public Version Status
- Update
- Public Device Record Key
- a1c232bb-25f3-4902-9b46-5aab85a6cdbb
Device Description
Pemphigus Foliaceus Control
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55139 | Skin 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 antibodies to skin in a clinical specimen, using a fluorescent immunoassay method. This test is typically used to aid the diagnosis of skin disorders (e.g., autoimmune bullous dermatoses such as pemphigus vulgaris, paraneoplastic pemphigus, or dermatitis herpetiformis); antibodies detected are typically directed at structural proteins of the skin and/or superficial mucosa (e.g., gliadin, desmoglein, collagen, endomysium). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845714003707 | GS1 |
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | ml |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius