3 x 4% E-Gel 48 Gels EGEL48

GUDID 10888234500667

For Use with ThromboType and ThromboType1

IMMUCOR GTI DIAGNOSTICS, INC.

Multiple human platelet antigen (HPA) typing IVD, reagent
Primary Device ID10888234500667
NIH Device Record Key2ce6ac99-76c1-4324-aab9-21eb3eef6697
Commercial Distribution StatusIn Commercial Distribution
Brand Name3 x 4% E-Gel 48 Gels
Version Model NumberEGEL48
Catalog NumberEGEL48
Company DUNS606034197
Company NameIMMUCOR GTI DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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-Counterfalse

Customer Support Contacts

Phone855-466-8267
Emailwaukeshatechsupport@immucor.co
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234500667 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYPTest,Platelet Antibody

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-01

Devices Manufactured by IMMUCOR GTI DIAGNOSTICS, INC.

10888234500827 - Dilution Solution2023-07-31 For Use with HLA-SSO Typing Kits
10888234500841 - LIFECODES LifeScreen XP2023-07-19 LIFECODES LifeScreen XP is a manual, qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class I
10888234400332 - LIFECODES LSA Class I 2022-04-14 LIFECODES LSA Class I is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient mat
10888234400349 - LIFECODES LSA Class II 2022-04-14 LIFECODES LSA Class II is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient ma
10888234500810 - LIFECODES MATCH IT! Antibody Software v1.42022-02-28
10888234500803 - LIFECODES MATCH IT!™ DNA Software v1.32020-03-05
10888234500063 - LIFECODES® B-Screen® 2019-12-16 LIFECODES B-Screen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodie
10888234500094 - LIFECODES® QuikScreen® 2019-12-16 LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibod
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.