FDA UDI
In Commercial Distribution
🇺🇸 United States
Ansh Labs Unconjugated Estriol EIA
DI: 00853592008271
·
Model: AL-138
·
Ansh Labs, LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ansh Labs Unconjugated Estriol EIA
- Primary DI
- 00853592008271
- Version / Model
- AL-138
- Catalog Number
- AL-138
- Company Name
- Ansh Labs, LLC
- Labeler DUNS
- 057752914
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-02
- Public Version
- 1
- Public Version Date
- 2021-06-10
- Public Version Status
- New
- Public Device Record Key
- c8b4f1dd-6bcc-4ea3-8a0b-3b54942be76b
Device Description
The Unconjugated Estriol Enzyme Immunoassay (EIA) Kit provides materials for the quantitative measurement of unconjugated estriol in serum. This assay is intended for in vitro Diagnostic Use Only. The test may help aid in the diagnosis and treatment of fetoplacental distress.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63779 | Free estriol (oestriol) 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 free estriol (oestriol) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically measured in maternal blood, urine or saliva as a marker of foetal health, gestational age, or fetoplacental distress typically in pregnancies complicated by diabetes, hypertension, or prolonged gestation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853592008271 | GS1 |
Customer Contacts
- Phone
- (281) 404-0260
- [email protected]