FDA.report

BioPlex 2200

Primary DI
00847865000666
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
6652050
Catalog number
6652050
Device description
APLS IgM Reagent Pack
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MSVSystem,test,antibodies,b2 - glycoprotein i (b2 - gpi)

Product Code Classifications

CodeDeviceSpecialtyClass
MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)Immunology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847865000666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865000666008478650006668478650006660847865000666

GMDN Terms

TermDefinition
Phospholipid antibody IVD, kit, multiplexA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antiphospholipid antibodies associated with antiphospholipid syndrome, in a clinical specimen, using a multiplex method.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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03610520540930Quest Diagnostics9459452023-10-09
03610521168942Geenius72480724802023-07-28
03610522162239Geenius12012482120124822023-07-28
03610522162260Geenius12012484120124842023-07-28
03610522168064Geenius12012851120128512023-07-28

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08426951289264QUANTA Flash® B2GP1 IgG Reagents INOVA DIAGNOSTICS, INC.MSV2019-09-27
08426951289271QUANTA Flash® B2GP1 IgM ReagentsINOVA DIAGNOSTICS, INC.MSV2019-09-27
08426951298778HemosIL AcuStar Anti-B2GPI Domain 1INSTRUMENTATION LABORATORY COMPANYMSV2018-07-17
B24235B2SHUE010Anti-Beta 2 Glycoprotein Screen ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.MSV2017-08-28
00845714002427Immco Diagnostics, IncIMMCO DIAGNOSTICS, INC.MSV2017-07-11
00845714002434Immco DIagnostics, Inc.IMMCO DIAGNOSTICS, INC.MSV2017-07-11
00845714002441Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.MSV2017-07-11
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04250289503082AESKULISA® ß2-Glyco-GM Aesku.Diagnostics GmbH & Co. KGMSV2017-03-02
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04250289502825AESKULISA® ß2-Glyco-AAesku.Diagnostics GmbH & Co. KGMSV2017-02-28
04250289502832AESKULISA® ß2-Glyco-GM Aesku.Diagnostics GmbH & Co. KGMSV2017-02-28
04250289502849AESKULISA® ß2-Glyco-Check Aesku.Diagnostics GmbH & Co. KGMSV2017-02-28
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04250289500852AESKULISA® ß2-Glyco-AAesku.Diagnostics GmbH & Co. KGMSV2016-09-27
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