Simmler, Inc.

GUDID 00851318008000

Fetal Cell Stain Kit 300 Test

SIMMLER INC

Haemoglobin F (HbF) IVD, reagent
Primary Device ID00851318008000
NIH Device Record Keyfd7cdcb2-f262-48e9-9cf8-506bb56a3f44
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimmler, Inc.
Version Model NumberS0412-00
Company DUNS056955776
Company NameSIMMLER INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Phone6363768347
Emailcustomerservice@simmler.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851318008000 [Primary]

FDA Product Code

GHQStain, Fetal Hemoglobin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-10-19

On-Brand Devices [Simmler, Inc.]

00851318008048Fetal Cell Fixing Solution
00851318008031Fetal Cell Citrate Buffer
00851318008024Fetal Cell Staining Solution
00851318008017Fetal Cell Stain Kit 100 Test
00851318008000Fetal Cell Stain Kit 300 Test

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