FDA.reportPublic FDA data

N/A

Primary DI
00810047420279
Brand
N/A
Company
Scientific Device Laboratory, Inc.
Model
668
Device description
Snap n' Digest Large 150ml [10 bottles/box]
Published
2023-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810047420279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810047420279008100474202798100474202790810047420279

GMDN Terms#

Term, Definition table
TermDefinition
Sputum liquefaction/decontamination reagent IVDA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the liquefaction, digestion, and/or decontamination of a sputum specimen suspected of containing microorganisms associated with respiratory disease (e.g., Streptococcus pneumoniae, Mycobacterium tuberculosis) in preparation for further processing.

Regulatory Flags#

DUNS number
115927956
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810047422075N/A49452024-08-08
00810047420293N/A7452023-01-30
00810047420323N/A7532023-01-30
00810047421061N/A745-12023-01-31
00810047422068N/A345-1002024-07-11
00810047422051N/A5152024-04-17
00810047422044N/A5202024-04-04
00810047422037N/A4912024-02-28
00810047422013N/A495-32024-01-09
00810047422020N/A4852024-01-09
00810047421993N/A5222023-09-21
00810047422006N/A5122023-09-21
00810047421986N/A373-C2023-08-31
00810047421832Scientific Device Laboratory6442023-08-14
00810047421962N/A4602023-06-12
00810047421979N/A4902023-06-12
00810047421863N/A6602023-06-08
00810047421870N/A4552023-06-08
00810047421887N/A3532023-06-08
00810047421894N/A353-A2023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05407013460213mRNA Buffer 103 : 200L BagLonza VerviersPPM2026-09-24
05407013460237mRNA Buffer 112 : 200L BagLonza VerviersPPM2026-09-24
05407013460244mRNA Buffer 112 : 1L Bag sampleLonza VerviersPPM2026-09-24
05407013460251mRNA Buffer 113 : 1L Bag sampleLonza VerviersPPM2026-09-24
05407013460268mRNA Buffer 113 : 200L BagLonza VerviersPPM2026-09-24
05407013460282Bulk Packaged ster. filtered WFI - 1LLonza VerviersPPM2026-09-24
04015630967162ISH Peroxidase InhibitorVentana Medical Systems, Inc.PPM2026-07-13
04049016151272FITC-labelled anti-human IgG (primate absorbed)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151289Biotin-labelled anti-human IgGEUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151296FITC-labelled Avidin (biotin affine)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151630FITC-labelled anti-human IgG (primate absorbed)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
00846405014194Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
00846405023417Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
00846405012305Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012312Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012329Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012411Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012428Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012435Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012459Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012466Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012473Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012497Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012503Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012510Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012527Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012534Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012541Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012558Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08