hema-screen Mailing Envelopes

GUDID 10722355002122

Fecal Occult Blood Reagent, Guaiac

IMMUNOSTICS COMPANY, INC

Home faecal specimen collection kit
Primary Device ID10722355002122
NIH Device Record Key3350e66a-d5b1-4e54-9169-b5f694738a23
Commercial Distribution StatusIn Commercial Distribution
Brand Namehema-screen Mailing Envelopes
Version Model NumberHSME-100
Company DUNS119214195
Company NameIMMUNOSTICS COMPANY, INC
Device Count100
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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
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
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
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
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110722355002122 [Primary]
GS180722355002121 [Unit of Use]

FDA Product Code

KHEREAGENT, OCCULT BLOOD

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-04-21
Device Publish Date2016-09-23

Devices Manufactured by IMMUNOSTICS COMPANY, INC

20722355001122 - hema-screen2025-03-31 Fecal Occult Blood Reagent, Guaiac
10722355001156 - hema-screen SPECIFIC2025-03-31 Immunological Fecal Occult Blood test
10722355001163 - Detector C-Reactacol2025-03-31 A rapid color enhanced latex slide test for the detection of C-Reactive Protein
10722355001170 - Detector C-Reactacol2025-03-31 A rapid color enhanced latex slide test for the detection of C-Reactive Protein
10722355001187 - Detector Lex-CRP2025-03-31 A rapid undiluted latex slide test for the detection of C-Reactive Protein
10722355001194 - Detector Lex-CRP2025-03-31 A rapid undiluted latex slide test for the detection of C-Reactive Protein
10722355001200 - Detector Color IM2025-03-31 A simple color enhanced slide test for the detection of infectious mononucleosis
10722355001217 - Detector Color IM2025-03-31 A simple color enhanced slide test for the detection of infectious mononucleosis

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.