Detector hCG

GUDID 10722355001415

For the detection of hCG in urine to aid in the determination of pregnancy

IMMUNOSTICS COMPANY, INC

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Primary Device ID10722355001415
NIH Device Record Keyb91f45a6-3eff-448b-a1f9-1f69ea249cd6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDetector hCG
Version Model NumberIHDOTC
Company DUNS119214195
Company NameIMMUNOSTICS COMPANY, INC
Device Count1
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110722355001415 [Primary]

FDA Product Code

JHIVisual, pregnancy hCG, prescription use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-07-06
Device Publish Date2016-09-24

On-Brand Devices [Detector hCG]

10722355002061For the qualitative detection of hCG in urine
10722355001415For the detection of hCG in urine to aid in the determination of pregnancy
10722355001316For the qualitative detection of hCG in urine
10722355001309For the qualitative detection of hCG in urine
10722355001293For the qualitative detection of hCG in urine

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