SICKLEDEX 217661

GUDID 00844509002024

A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human blood or sickle cell control material. Contains 12 tests.

STRECK, INC.

Haemoglobin S (HbS) IVD, control
Primary Device ID00844509002024
NIH Device Record Key780b0b05-acbc-42ec-9c0d-888d1e58bedd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSICKLEDEX
Version Model Number217661
Catalog Number217661
Company DUNS072915986
Company NameSTRECK, INC.
Device Count1
DM Exempttrue
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

Phone1-800-228-6090
Emailcustserv@streck.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844509002024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GHMTest, Sickle Cell

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 Date2016-09-19

On-Brand Devices [SICKLEDEX]

00844509002048A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human b
00844509002031A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human b
00844509002024A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human b

Trademark Results [SICKLEDEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SICKLEDEX
SICKLEDEX
80986052 0986052 Dead/Cancelled
Johnson & Johnson
0000-00-00
SICKLEDEX
SICKLEDEX
72319349 0889582 Live/Registered
ORTHO PHARMACEUTICAL CORPORATION
1969-02-17

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