FDA.reportPublic FDA data

Sample Storage Reagent

Primary DI
06955792701557
Brand
Sample Storage Reagent
Company
Sansure Biotech Inc.
Model
LU-X1002E-48-6
Published
2025-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSGCulture Media, Non-Selective And Non-Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSGCulture Media, Non-Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06955792701557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06955792701557069557927015576955792701557

GMDN Terms#

Term, Definition table
TermDefinition
General tissue specimen container IVD, fixative/salineA covered receptacle (single- or multiple-compartment) containing a tissue fixation or preservation solution [e.g., formalin, saline] intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain patient-contact tissue specimen sampling/excision devices. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(203)726-7873techsupport@lusisbio.com

Regulatory Flags#

DUNS number
421167832
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06955792702844Nucleic Acid Extraction and Purification Kit 1.0Xvance 48C2026-03-25
06955792702851Nucleic Acid Extraction and Purification Kit 1.0Xvance 96A2026-03-25
06955792702868Nucleic Acid Extraction and Purification Kit 2.0Xvance 482026-03-25
06955792702875Nucleic Acid Extraction and Purification Kit 2.0Xvance 962026-03-25
06955792702882Nucleic Acid Extraction and Purification Kit 3.0Xvance 48A2026-03-25
06955792702899Nucleic Acid Extraction and Purification Kit 3.0Xvance 48B2026-03-25
06955792701717Q-Vera Prima 96 qPCR Instrument96-well, 0.2 mL block (Model: Q-Vera Prima 96 TAMR2025-11-19
06955792701670Q-Vera Prima 96 qPCR Instrument96-well, 0.2 mL block (Model: Q-Vera Prima 96 AF402025-10-16
06955792700857Q-Vera Pico 6X qPCR Instrument48-well (8 wells x 6), 0.2 mL blocks2025-09-18
06955792701564Sample Storage ReagentLU-X1002E-48-32025-09-18
06955792701571Sample Storage ReagentLU-X1002E-48-12025-09-18
06955792701649Sample Storage ReagentLU-X1002E-48-3b2025-09-18
06955792701656Sample Storage ReagentLU-X1002E-48-6b2025-09-18
06955792700864Q-Vera Prima 96 qPCR Instrument96-well, 0.2 mL block2024-10-29
06955792714977Nucleic Acid Extraction-Purification Kit 4.0S50016E-48B2023-09-18
06955792714960Nucleic Acid Extraction-Purification Kit 4.0S50016E-48A2023-09-15
06955792714694NATCH S-F11C SystemS-F11C (US)2023-08-10
06955792713666Nucleic Acid Extraction-Purification Kit 3.0S50016E-482023-07-28
06955792713673Nucleic Acid Extraction-Purification Kit 3.0S50016E-962023-07-28
06955792714366Nucleic Acid Extraction-Purification Kit 2.0S50016E-48C2023-07-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B645GB477EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645T0006EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
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30382902976425BD BBL™ Fluid Thioglycollate Medium, EnrichedBECTON, DICKINSON AND COMPANYJSG2023-11-14
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00848838004612REMELREMEL, INC.JSG2022-12-23