FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]
DI: 08305900070248
·
Model: 7024
·
BIOMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]
- Primary DI
- 08305900070248
- Version / Model
- 7024
- Company Name
- BIOMERICA, INC.
- Labeler DUNS
- 067647321
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-07
- Public Version
- 4
- Public Version Date
- 2021-09-02
- Public Version Status
- Update
- Public Device Record Key
- 7aefee90-652d-48fe-b50e-3ae61b8ffd7d
- Distribution End Date
- 2020-07-01
Device Description
The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum. This assay is intended for in vitro diagnostic use.
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| JKR | Radioimmunoassay, Calcitonin | Clinical Chemistry | 862.1140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54085 | Calcitonin IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the quantitative measurement of calcitonin in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08305900070248 | GS1 |
Customer Contacts
- Phone
- +1 949 645 2111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K982491 | 000 |