RESOLVE Systems Neonatal Hemoglobin Kit FR-9400

GUDID 06438147000814

For detection of normal and variant hemoglobins.

Wallac Oy

Multiple haemoglogbin subtype IVD, kit, electrophoresis
Primary Device ID06438147000814
NIH Device Record Key2b0ebc83-3457-4795-aece-be017220fa34
Commercial Distribution StatusIn Commercial Distribution
Brand NameRESOLVE Systems Neonatal Hemoglobin Kit
Version Model NumberFR-9400
Catalog NumberFR-9400
Company DUNS540156544
Company NameWallac Oy
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106438147000814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKAAbnormal Hemoglobin Quantitation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-28
Device Publish Date2016-02-02

On-Brand Devices [RESOLVE Systems Neonatal Hemoglobin Kit]

06438147000814For detection of normal and variant hemoglobins.
06438147000791For detection of normal and variant hemoglobins.

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