← Back to catalogue
BioHermes Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit
FDA UDIIdentity
- Trade Name
- BioHermes Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit FDA UDI
- Generic Name
- Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- COM-S0101E0 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06935784400286 FDA UDI
- GMDN Term
- Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, enzyme immunoassay (EIA)
BioHermes Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — FDA UDI — listed in FDA…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Sources (1)
- FDA UDI ff646e50-3c41-460e-b61e-4f5516ee46d8 33 fields · synced Jun 8, 2026