FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Hytec Automated EIA System for Total IgE and Specific IgE
DI: 00816879022322
·
Model: 288-6002-350
·
HYCOR BIOMEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Hytec Automated EIA System for Total IgE and Specific IgE
- Primary DI
- 00816879022322
- Version / Model
- 288-6002-350
- Company Name
- HYCOR BIOMEDICAL LLC
- Labeler DUNS
- 010558476
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 6
- Public Version Date
- 2024-09-06
- Public Version Status
- Update
- Public Device Record Key
- 0f1d1b18-c96d-495d-87c9-a1c74b8eeac9
- Distribution End Date
- 2023-09-30
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | Immunology | 866.5750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56718 | Enzyme immunoassay (EIA) analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers, in a clinical specimen, using an immunological method which utilizes an enzyme-based detection system with sample processing, data processing and/or data display software. It uses enzyme-labelled antigens or antibodies and a solid-phase binding support (e.g., beads, microplates) to measure the substance of interest, typically antigens, antibodies, drugs, or endogenous substances in body fluids. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816879022322 | GS1 |
Customer Contacts
- Phone
- 800-382-2527
- [email protected]