FDA.reportPublic FDA data

AmnioTest (Nitrazine yellow swab)

Primary DI
10628429001223
Brand
AmnioTest (Nitrazine yellow swab)
Company
PRO-LAB, INCORPORATED
Model
PL.901
Catalog number
PL.901
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.
Published
2022-12-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HIOSampler, Amniotic Fluid (Amniocentesis Tray)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIOSampler, Amniotic Fluid (Amniocentesis Tray)Obstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914419000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914419000AMNIOTEST(TM)Pro-Lab, Inc.1993-09-01HIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10628429001223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1062842900122310628429001223

GMDN Terms#

Term, Definition table
TermDefinition
Amniotic fluid leak detectorA 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.

Sterilization Methods#

Method table
Method
Microwave Radiation

Regulatory Flags#

DUNS number
960418395
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20628429001220AmnioTest (Nitrazine yellow swab 20 box)PL.901-20PL.901-202022-12-26
30628429001227AmnioTest (Nitrazine yellow swab 100 box)PL.901PL.9012022-12-26
10628429001742Legionella DFA Mounting MediumPL.213PL.2132022-12-25
10628429001049Prolex E. coli O157 Latex Test Reagent Kit (50 tests)PL.070BPL.070B2022-12-26
10628429001056Prolex E. coli O157 Latex Test Reagent Kit (100 tests)PL.071BPL.071B2022-12-26
10628429001100Prolex E. coli O157 Latex Reagent Control NegativePL.076BPL.076B2022-12-26
10628429001124Prolex E. coli Non-O157 Identification KitPL.1070PL.10702022-12-26
10628429001131Prolex E. coli O26 Latex ReagentPL.1071PL.10712022-12-26
10628429001148Prolex E. coli O45 Latex ReagentPL.1072PL.10722022-12-26
10628429001155Prolex E. coli O103 Latex ReagentPL.1073PL.10732022-12-26
10628429001162Prolex E. coli O111 Latex ReagentPL.1074PL.10742022-12-26
10628429001179Prolex E. coli O121 Latex ReagentPL.1075PL.10752022-12-26
10628429001186Prolex E. coli O145 Latex ReagentPL.1076PL.10762022-12-26
10628429001193Prolex E. coli Non-O157 Negative Control Latex ReagentPL.1077PL.10772022-12-26
10628429001209Prolex E. coli O91 Latex ReagentPL.1078PL.10782022-12-26
10628429001216E. coli O157 Antiserum (3ml)PL.6250PL.62502022-12-26
10628429001254AmnioTest Colour CardsPL.902PL.9022022-12-26
10628429000080Prolex Streptococcal Grouping Latex KitPL.030PL.0302022-12-25
10628429000110Prolex Streptococcal Grouping Reagent Latex Suspension Group APL.031PL.0312022-12-25
10628429000134Prolex Streptococcal Grouping Reagent Latex Suspension Group BPL.032PL.0322022-12-25

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