FDA.reportPublic FDA data

Globe Scientific

Primary DI
00840095606349
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
5112
Device description
ORGANON TEKNIKA: Test Trays, for use with the Coag-A-Mate XM analyzer, 100/Box, 10 Boxes/Case
Published
2019-11-26
Public version status
Update
Distribution status
Not 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
00840095606349PrimaryGS10
00840095611237Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095606349008400956063498400956063490840095606349
00840095611237008400956112378400956112370840095611237

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory analyser cuvette IVD, single-useA non-sterile, small volume, rectangular column designed to contain a clinical specimen, reagent, or other material for testing procedures performed by a laboratory analyser. It is transparent to allow light to travel through sample and is typically made of plastic, glass or quartz with a flat base and an open top. 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
15099590812478DxUBeckman Coulter, Inc.LXG2026-06-24
08435389828150SAMPLE PREPARATION KITBIOTECHNOLOGY INSTITUTE SLLXG2026-05-27
00816394021855Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021930Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021947Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021954Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021985Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021992Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022005Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022012Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022050Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022067Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022074Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022081Helmer ScientificHELMER, INC.LXG2026-05-13
15099590695743iChemVELOCITYBECKMAN COULTER IRELAND INC.LXG2026-04-27
09120123910022Anchor Tips, 300uLSTRATEC Consumables GmbHLXG2026-01-14
26974573531033CellproSuzhou CellPro Biotechnology Co., Ltd.LXG2025-11-21
10818207025071Endocator Starter KitVista DentalLXG2025-11-07
10818207025088Endocator Swabs (20pk)Vista DentalLXG2025-11-07
10849832025815Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-23
10849832024238Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
10849832024276Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
10849832027055Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
00810100050269KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050283KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050306KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050511KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050528KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050535KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050542KBMEDKB Medical (group), Inc.LXG2025-05-22