Prothrombin (FII) HyBeacon Gen II Primer Pair MOL9773

GUDID 10816101027221

DIASORIN MOLECULAR LLC

Assay development analyte-specific reagent IVD
Primary Device ID10816101027221
NIH Device Record Keyb78d11f6-7139-43c0-b01d-7691f23477e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameProthrombin (FII) HyBeacon Gen II Primer Pair
Version Model NumberMOL9773
Catalog NumberMOL9773
Company DUNS080271715
Company NameDIASORIN MOLECULAR LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone1-562-240-6500
EmailTS.Molecular@DiaSorin.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110816101027221 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-02
Device Publish Date2024-09-24

Devices Manufactured by DIASORIN MOLECULAR LLC

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10816101027221 - Prothrombin (FII) HyBeacon Gen II Primer Pair2024-10-02
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10816101027283 - Monkeypox Primer Pair2024-08-30
10816101027290 - Human GAPDH Endogenous Primer Pair2024-08-30
20816101027198 - Simplexa™ C. auris Direct2024-07-29
20816101027211 - Simplexa™ C. auris Positive Control Pack2024-07-29
20816101027235 - Simplexa™ C. auris Sample Prep Kit2024-07-29
10816101022240 - DxSelect™ Amber Sample Diluent2024-07-09

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