LEADER 5741889

GUDID 50096295141547

LDR One Step Pregnancy Test 2 tests

Cardinal Health 110, Inc.

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, agglutination, rapid
Primary Device ID50096295141547
NIH Device Record Key17c38be2-1692-4cc6-b9bb-09d384f330d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEADER
Version Model Number5741889
Catalog Number5741889
Company DUNS063997360
Company NameCardinal Health 110, Inc.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx
Phone+1(800)200-6313
Emailxxx@xxx.xxx

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100096295141542 [Primary]
GS110096295141549 [Unit of Use]
GS150096295141547 [Package]
Contains: 00096295141542
Package: CASE [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-24
Device Publish Date2022-01-14

On-Brand Devices [LEADER]

50096295122294LDR Earloop Face Masks 20 single-use
50096295141547LDR One Step Pregnancy Test 2 tests
50096295141530LDR Early Detection Pregnancy Test 3 ea
50096295141523LDR One Step Pregnancy Test 2 ea
50096295141516LDR One Step Pregnancy Test 1 ea
50096295141509LDR Early Detection Pregnancy Test 2 ea
50096295141158LDR Advanced Wound Care Silicone Tape 1 in x 4 yards 1 each
50096295141172LDR Sterile Transparent Waterseal Dressing 4in x 4.75in 4 ea
50096295141196LDR Paper Tape with Dispenser 1 inch x 10 yards 1 roll
30096295141147LDR No Hurt Wrap 3inx80in 1 ea
50096295141134LDR Paper Tape 2 in x 10 yards 1 roll
50096295142469LDR Waterproof Sterile Large Adhesive Pads 3x4in 6 count
50096295142452LDR Flexible Fabric Adhesive Bandage Sterile 100 each assorted
50096295142445LDR Heavy Duty Waterproof Adhesive Bandages Sterile 2x4in 10 count
50096295142438LDR Cushioned Waterproof Knee & Elbow Bandages Sterile 2x4in 8 count
50096295142421LDR Heavy Duty Flexible Fabric Adhesive Bandages Sterile 2x4 inch 10 count
50096295142414LDR Flexible Fabric Adhesive Bandage Sterile 2x4in 10 each
00096295135381LDR First Aid Kit 70 pieces
00096295135374LDR First Aid Kit 140 pieces
50096295142827LDR Sheer Adhesive Bandage Sterile 3/4" x 3" 100 count
50096295142735LDR Nitrile Exam Gloves Extra Large non-sterile Powder-free 100 count
50096295142728LDR Nitrile Exam Gloves Large non-sterile Powder-free 100 count
50096295142711LDR Nitrile Exam Gloves Medium non-sterile Powder-free 100 count
50096295142704LDR Nitrile Exam Gloves Small non-sterile Powder-free 100 count
50096295142698LDR Vinyl Exam Gloves Small non-sterile Powder-free 100 count
50096295142681LDR Vinyl Exam Gloves Extra large non-sterile Powder-free 100 count
50096295142674LDR Vinyl Exam Gloves Large non-sterile Powder-free 100 count
50096295142667LDR Vinyl Exam Gloves Medium non-sterile Powder-free 100 count
50096295143855LDR Talking Blood Pressure Monitor with Wide Range Arm Cuff 1 monitor Kit
50096295143473LDR Easy Ovulation Test Analog 10ct + 1 Analog Pregnancy Test

Trademark Results [LEADER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LEADER
LEADER
98683492 not registered Live/Pending
Heartland Footwear Inc.
2024-08-05
LEADER
LEADER
98581059 not registered Live/Pending
LEADER ELECTRONICS CORPORATION
2024-06-03
LEADER
LEADER
97350922 not registered Live/Pending
MODA FOODS LLC
2022-04-07
LEADER
LEADER
88649986 not registered Live/Pending
Leader Technologies, Incorporated
2019-10-10
LEADER
LEADER
88648937 not registered Live/Pending
Leader Technologies, Incorporated
2019-10-10
LEADER
LEADER
88644972 not registered Live/Pending
Rosen's, Inc.
2019-10-07
LEADER
LEADER
87936678 not registered Live/Pending
Must Have Info Inc.
2018-05-25
LEADER
LEADER
86876788 not registered Live/Pending
Leader Drugstores, Inc.
2016-01-15
LEADER
LEADER
86876782 not registered Live/Pending
Leader Drugstores, Inc.
2016-01-15
LEADER
LEADER
86852768 5423902 Live/Registered
The Hilsinger Company
2015-12-17
LEADER
LEADER
86852696 5423901 Live/Registered
The Hilsinger Company
2015-12-17
LEADER
LEADER
86663286 4889242 Live/Registered
ZhongKeRuiDeng Science & Technology Development (Beijing) Co., Ltd.
2015-06-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.