FDA UDI
In Commercial Distribution
🇺🇸 United States
AmnioTest (Nitrazine yellow swab 20 box)
DI: 20628429001220
·
Model: PL.901-20
·
PRO-LAB, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AmnioTest (Nitrazine yellow swab 20 box)
- Primary DI
- 20628429001220
- Version / Model
- PL.901-20
- Catalog Number
- PL.901-20
- Company Name
- PRO-LAB, INCORPORATED
- Labeler DUNS
- 960418395
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-26
- Public Version
- 1
- Public Version Date
- 2023-01-03
- Public Version Status
- New
- Public Device Record Key
- 282f27ca-f73a-49a7-920c-99c5f5eda65c
Device Description
The AmnioTest™ is designed to assist in the detection of rupture of the fetal membranes, based on elevation of the pH in the upper vagina consistent with leakage of amniotic fluid. The sterile swab impregnated with nitrazine yellow dye, offers a rapid, reliable, cost effective and simple to use point-of-care test to aid in the detection of amniotic fluid in patients with suspected PROM.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Microwave Radiation
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | Obstetrics/Gynecology | 884.1550 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65199 | Amniotic fluid leak detector | A device designed to help identify amniotic fluid in the vaginal secretions of a pregnant woman to confirm membrane rupture (normal or premature). The device typically involves a colour indicator that signals within the pH range of amniotic fluid (above 6.5) after contact. The device may consist of a panty liner with attached indicator strip, or a nitrazine-impregnated swab or paper. The device may be used in the home or in a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20628429001220 | GS1 |