FDA UDI
In Commercial Distribution
🇺🇸 United States
PrisMatic ELISA Analyzer
DI: 00816870020068
·
Model: IN013
·
MONOBIND, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PrisMatic ELISA Analyzer
- Primary DI
- 00816870020068
- Version / Model
- IN013
- Catalog Number
- IN013
- Company Name
- MONOBIND, INC.
- Labeler DUNS
- 083155515
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-13
- Public Version
- 1
- Public Version Date
- 2024-09-23
- Public Version Status
- New
- Public Device Record Key
- 1b14aa16-e511-44ba-8acc-4f1209d66686
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| JJQ | COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE | Clinical Chemistry | 862.2300 | 1 |
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 | 00816870020068 | GS1 |
Customer Contacts
- Phone
- +1(949)951-2665
- [email protected]