FDA.reportPublic FDA data

iFlash-Beta2-Glycoprotein I IgM

Primary DI
06925912718840
Brand
iFlash-Beta2-Glycoprotein I IgM
Company
Shenzhen YHLO Biotech Co., Ltd.
Model
C89052M
Device description
"""Beta"" is identical to the second letter of Greek alphabet. Because GUDID system couldn't recognize this letter, it is replaced by ""Beta"". The acutal product name would be showed with the second letter of Greek alphabet instead of ""Beta""."
Published
2022-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DDNBeta-2-Glycoprotein I, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DDNBeta-2-Glycoprotein I, Antigen, Antiserum, ControlImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06925912718840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06925912718840069259127188406925912718840

GMDN Terms#

Term, Definition table
TermDefinition
Beta-2-glycoprotein I antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to beta-2-glycoprotein I in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420735989
Device count
1
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
06925912718833iFlash-Anti-Beta2-Glycoprotein IShenzhen YHLO Biotech Co., Ltd.DDN2023-12-31
06925912717836iFlash-Anti-Beta2-Glycoprotein IShenzhen YHLO Biotech Co., Ltd.DDN2022-10-26
06925912718857iFlash-Beta2-Glycoprotein I IgGShenzhen YHLO Biotech Co., Ltd.DDN2022-10-26
04049016027188Anti-ß2-Glycoprotein 1 ELISA (IgA)EUROIMMUN Medizinische Labordiagnostika AGDDN2016-09-24
04049016027195Anti-ß2-Glycoprotein 1 ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGDDN2016-09-24
04049016027201Anti-ß2-Glycoprotein 1 ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGDDN2016-09-24
04049016027218Anti-ß2-Glycoprotein 1 ELISA (IgAGM)EUROIMMUN Medizinische Labordiagnostika AGDDN2016-09-24