FDA.report

BioPlex 2200

Primary DI
03610522015597
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
12007240
Catalog number
12007240
Device description
U.S. IFU (United States) Manual & CDs, BioPlex 2200 Syphilis Total & RPR IFU 4.3v2
Published
2018-02-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LIPENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Product Code Classifications

CodeDeviceSpecialtyClass
LIPEnzyme Linked Immunoabsorption Assay, Treponema PallidumMicrobiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03610522015597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03610522015597036105220155973610522015597

GMDN Terms

TermDefinition
Treponema pallidum reagin antibody IVD, reagentA 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 qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)224-6723TechSupport.USSD@bio-rad.com

Regulatory Flags

DUNS number
884513334
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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03610522231096Liquichek12015646120156462024-05-24
03610522231102Liquichek12015647120156472024-05-24
03610522231119Liquichek12015648120156482024-05-24
03610522231461InteliQ12015705120157052024-05-24
03610522231478InteliQ12015706120157062024-05-24
03610522231485InteliQ12015707120157072024-05-24
03610522231492InteliQ12015708120157082024-05-24
03610522231508InteliQ12015709120157092024-05-24
03610522354658Liquichek12019576120195762024-05-24
03610522354665InteliQ12019558120195582024-05-24
00847661004080Quest Diagnostics9559552023-10-09
03610520540916Quest Diagnostics9309302023-10-09
03610520540923Quest Diagnostics9359352023-10-09
03610520540930Quest Diagnostics9459452023-10-09
03610521168942Geenius72480724802023-07-28
03610522162239Geenius12012482120124822023-07-28
03610522162260Geenius12012484120124842023-07-28
03610522168064Geenius12012851120128512023-07-28

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03610522207992BioPlexBIO-RAD LABORATORIES, INC.LIP2023-07-28
07613336171950Elecsys SyphilisRoche Diagnostics GmbHLIP2022-03-15
07613336171998Elecsys SyphilisRoche Diagnostics GmbHLIP2022-03-15
00630414599892Atellica IM Syph QCSiemens Healthcare Diagnostics Inc.LIP2020-09-24
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05391516746588Bio-StatCLARK LABORATORIES, INC.LIP2019-12-30
05391516747424Phoenix BiotechCLARK LABORATORIES, INC.LIP2019-12-30
05391516746687Bio-RadCLARK LABORATORIES, INC.LIP2019-12-27
05391516746861Trinity BiotechCLARK LABORATORIES, INC.LIP2019-12-27
05391516746892Trinity BiotechCLARK LABORATORIES, INC.LIP2019-12-27
05391516746908Trinity BiotechCLARK LABORATORIES, INC.LIP2019-12-27
05391516747226Trinity BiotechCLARK LABORATORIES, INC.LIP2019-12-27
00380740138196AlinityAbbott GmbH & Co. KGLIP2018-07-11
00630414599885Atellica IM SyphSiemens Healthcare Diagnostics Inc.LIP2018-02-06
00868926000302Syphilis Health CheckVEDALABLIP2017-05-19
08056771100618LIAISON® Treponema AssayDIASORIN SPALIP2016-09-24
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05391516745093Trinity BiotechCLARK LABORATORIES, INC.LIP2016-09-23
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05391516747400Phoenix BiotechCLARK LABORATORIES, INC.LIP2016-09-23
05391516747417Phoenix BiotechCLARK LABORATORIES, INC.LIP2016-09-23
05391516747431Phoenix BiotechCLARK LABORATORIES, INC.LIP2016-09-23
05391516747448Phoenix BiotechCLARK LABORATORIES, INC.LIP2016-09-23
05391516747462Phoenix BiotechCLARK LABORATORIES, INC.LIP2016-09-23