FDA UDI
In Commercial Distribution
🇺🇸 United States
NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodon
DI: 00810053950159
·
Model: F024
·
HYCOR BIOMEDICAL LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodon
- Primary DI
- 00810053950159
- Version / Model
- F024
- Catalog Number
- 8632350Z
- Company Name
- HYCOR BIOMEDICAL LLC
- Labeler DUNS
- 010558476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-20
- Public Version
- 1
- Public Version Date
- 2026-01-28
- Public Version Status
- New
- Public Device Record Key
- 97d6fc5f-4342-4f14-8535-9b5fe76fff3f
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 |
|---|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | Immunology | 866.5750 | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Clinical Chemistry | 862.2160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53782 | Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergens in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810053950159 | GS1 |
Customer Contacts
- Phone
- 800-382-2527
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252493 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius