FDA UDI
In Commercial Distribution
🇺🇸 United States
DBC Total Estrogens ELISA
DI: B261CANE6300
·
Model: CAN-E-630
·
Diagnostics Biochem Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DBC Total Estrogens ELISA
- Primary DI
- B261CANE6300
- Version / Model
- CAN-E-630
- Catalog Number
- CAN-E-630
- Company Name
- Diagnostics Biochem Canada Inc
- Labeler DUNS
- 207718438
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-10
- Public Version
- 1
- Public Version Date
- 2022-11-18
- Public Version Status
- New
- Public Device Record Key
- 4258edbc-8e2b-466a-9ce3-c780a2db9fb3
Device Description
For the quantitative measurement of Total Estrogens in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| JMD | Radioimmunoassay, Total Estrogens, Nonpregnancy | Clinical Chemistry | 862.1275 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63754 | Total estrogen (oestrogen) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total estrogen (oestrogen) hormones [estradiol, estriol, and estrone] in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis of sex steroid metabolism-related conditions (e.g., premature or delayed puberty), or assessment of fracture risk and monitoring of hormone replacement therapy in postmenopausal women. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B261CANE6300 | HIBCC |
Customer Contacts
- Phone
- 1-519-681-8731
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius