Phosphate Buffered Saline with Tween 20 (20X)

GUDID 00850042030080

Washing buffer. Also aids in reagent spreading on tissue samples.

Lumatas Biosystems, Inc.

Buffered isotonic saline reagent IVD
Primary Device ID00850042030080
NIH Device Record Key4503f938-92a5-42a4-a854-305922475c7a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhosphate Buffered Saline with Tween 20 (20X)
Version Model Number1
Company DUNS080169635
Company NameLumatas Biosystems, Inc.
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850042030080 [Primary]

FDA Product Code

NJTImmunohistochemistry Reagents And Kits

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-02
Device Publish Date2023-10-25

Devices Manufactured by Lumatas Biosystems, Inc.

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00810202560048 - goldFISH2025-08-11 BCL2 Dual Color Break Apart Probe
00810202560055 - goldFISH2025-08-11 BCL6 Dual Color Break Apart Probe
00810202560062 - goldFISH2025-08-11 IRF4 Dual Color Break Apart Probe
00810202560079 - goldFISH2025-08-11 CCND1/IGH Dual Color Dual Fusion Probe

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