BioHermes Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit
Basic Information
- Brand Name
- BioHermes Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit
- Primary DI
- 06935784400286
- Version / Model
- COM-S0101E0
- Company Name
- Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
- Labeler DUNS
- 528192913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-04
- Public Version
- 1
- Public Version Date
- 2022-01-12
- Public Version Status
- New
- Public Device Record Key
- ff646e50-3c41-460e-b61e-4f5516ee46d8
Device Description
Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit (Colloidal Gold) 1 Test/Kit lntended use: this combo test kit is used for in vitro diagnostic testing for qualitatively measuring the Insulin-like Growth Factor Binding Proteir-1 (IGFBP-1) and fetal Fibronectin (fFN) levels in the secretions of pregnant women patients. It can work as an auxiliary diagnosis of membrane rupture in pregnant women (including premature rupture of membranes) and also work as a method to predict the pregnancy status in labor (including premature delivery). Contents: 1.one dipstick in a sealed alurminum foil pouch with desiccant; 2.one tube of specimen extraction solution (1.0 ml), this phosphate-bufferedsolution contains preservatives; 3.one instruction for use.
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
- No
- 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 |
|---|---|---|---|---|
| 63759 | Insulin-like growth factor binding protein 1 (IGFBP-1) 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 insulin-like growth factor binding protein 1 (IGFBP-1) 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 | 06935784400286 | GS1 | ||||
| Package | 16935784400283 | GS1 | box | 25 | In Commercial Distribution |