FDA.reportPublic FDA data

Globe Scientific

Primary DI
00840095606134
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
3818
Device description
3818
Published
2019-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840095606134PrimaryGS10
00840095611077Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095606134008400956061348400956061340840095606134
00840095611077008400956110778400956110770840095611077

GMDN Terms#

Term, Definition table
TermDefinition
Drug-testing specimen collection kit IVDA covered receptacle and other associated materials/tools, available either [non-prescription] over-the-counter and/or to health professionals, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106793995
Device count
1000
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840095681674Globe ScientificGCC-P2026-03-16
00840095688840Globe Scientific 154005R2025-07-07
00840095688857Globe Scientific 154020R2025-07-07
00840095688864Globe Scientific 154035R2025-07-07
00840095688871Globe Scientific 154005RS2025-07-07
00840095688888Globe Scientific 154020RS2025-07-07
00840095688895Globe Scientific 154035RS2025-07-07
00840095688901Globe Scientific 154105RS2025-07-07
00840095688918Globe Scientific 154120RS2025-07-07
00840095688925Globe Scientific 154135RS2025-07-07
00840095688932Globe Scientific 154205RS2025-07-07
00840095688949Globe Scientific 154220RS2025-07-07
00840095688956Globe Scientific 154235RS2025-07-07
00840095688994Globe Scientific 154005F2025-07-07
00840095689007Globe Scientific 154020F2025-07-07
00840095689014Globe Scientific 154035F2025-07-07
00840095689021Globe Scientific 154005FS2025-07-07
00840095689038Globe Scientific 154020FS2025-07-07
00840095689045Globe Scientific 154035FS2025-07-07
00840095689052Globe Scientific 154105FS2025-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389830269HEATING OVEN H-PLUSBIOTECHNOLOGY INSTITUTE SLLXG2026-01-30
04250317501554PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317501578PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317536204PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317537577PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317554611PrecolumnChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317555281PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317558022PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
09120123910015Anchor Tips, 300uLSTRATEC Consumables GmbHLXG2026-01-14
09120123911012Stackable Cuvette, 1mLSTRATEC Consumables GmbHLXG2026-01-14
06979203760025Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-29
06979203760032Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-29
06979203760049Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-29
06979203760056Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-29
06979203760018Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-08
04049016152101Reagent tray for incubation of slidesEUROIMMUN Medizinische Labordiagnostika AGLXG2025-11-27
04049016152125Reagent tray for incubation of slidesEUROIMMUN Medizinische Labordiagnostika AGLXG2025-11-27
04250317510174TubeChromsystems Instruments + Chemicals GmbHLXG2025-07-31
04260170881090Q-graft control deviceHuman Med AGLXG2025-07-30
04260170881106Q-graft collectorHuman Med AGLXG2025-07-30
14260170881608Q-graft disposable setHuman Med AGLXG2025-07-30
14260170881615Q-graft centrifugation setHuman Med AGLXG2025-07-30
17290020288001CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288018CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288025CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288032CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288049CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288056CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288063CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288070CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20