BioHermes Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit - Insulin-like Growth Factor Binding Protein-1 & - Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

Duns Number:528192913

Device Description: Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit (Colloidal Gold) 1 Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit (Colloidal Gold) 1 Test/Kitlntended 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.

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More Product Details

Catalog Number

-

Brand Name

BioHermes Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit

Version/Model Number

COM-S0101E0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

ff646e50-3c41-460e-b61e-4f5516ee46d8

Public Version Date

January 12, 2022

Public Version Number

1

DI Record Publish Date

January 04, 2022

Additional Identifiers

Package DI Number

16935784400283

Quantity per Package

25

Contains DI Package

06935784400286

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1