FDA.reportPublic FDA data

Reaction vessel

Primary DI
06925912708513
Brand
Reaction vessel
Company
Shenzhen YHLO Biotech Co., Ltd.
Model
C6100
Device description
2000 pcs/box (2 bag/box, 1000 pcs/bag)
Published
2022-10-26
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
JRICuvette, Thermostated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRICuvette, ThermostatedClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06925912708513PrimaryGS10
06925912708506Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06925912708513069259127085136925912708513
06925912708506069259127085066925912708506

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory analyser cuvette IVD, single-useA small volume, rectangular column designed to contain a clinical specimen, reagent, or other material for in vitro diagnostic testing procedures performed by a laboratory analyser. It is transparent to allow light to travel through the contained material and is typically made of plastic, glass or quartz with a flat base and an open top. This is a single-use device.

Regulatory Flags#

DUNS number
420735989
Device count
2000
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06925912718512iFlash-T4C860262022-10-26
06925912718703iFlash-HCGC860122024-01-30
06925912718833iFlash-Anti-Beta2-Glycoprotein IC89027Z2023-12-31
06925912710424Chemiluminescence Immunoassay AnalyzeriFlash 3000-CC61112022-10-26
06925912710547Chemiluminescence Immunoassay AnalyzeriFlash 3000-CC61062022-10-26
06925912719205iFlash-Mycoplasma pn. IgMC88004M2022-10-26
06925912715290iFlash-Cleaning SolutionC899232022-10-26
06925912716044Wash BufferC800012022-10-26
06925912716075Trigger Solution (1×)C899982022-10-26
06925912716099Trigger Solution (1×)C899482022-10-26
06925912716105Pre-Trigger Solution (1×)C899992022-10-26
06925912716112Pre-Trigger Solution (1×)C899592022-10-26
06925912716129Pre-Trigger Solution (1×)C899492022-10-26
06925912716587Sample DiluentC899112022-10-26
06925912716600Sample DiluentC899122022-10-26
06925912716624Sample DiluentC899142022-10-26
06925912716631Sample DiluentC899152022-10-26
06925912716648Sample DiluentC899172022-10-26
06925912716679Sample DiluentC899182022-10-26
06925912716693Sample DiluentC899192022-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06925912708506Reaction vesselShenzhen YHLO Biotech Co., Ltd.JRI2022-10-26
05051700020909Tencell™ cuvettesTHE BINDING SITE GROUP LIMITEDJRI2022-07-22
00630414221588ADVIA Centaur® CuvettesSiemens Healthcare Diagnostics Inc.JRI2020-09-24