FDA.report

BioPlex 2200

Primary DI
00847865001175
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
6653850
Catalog number
6653850
Device description
Rubella & CMV 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
LFXENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Product Code Classifications

CodeDeviceSpecialtyClass
LFXEnzyme Linked Immunoabsorbent Assay, RubellaMicrobiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847865001175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865001175008478650011758478650011750847865001175

GMDN Terms

TermDefinition
Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Rubella virus in a clinical specimen, using a fluorescent immunoassay 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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00850049545686AccuDiag ™Diagnostic Automation, Inc.LFX2023-06-14
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B3507203600Gold Standard Diagnostics Is-Rubella IgG ELISA Test KitGOLD STANDARD DIAGNOSTICS CORP.LFX2020-07-27
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05391516746786Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-26
00630414599830Atellica IM Rub MSiemens Healthcare Diagnostics Inc.LFX2018-02-06
00630414599847Atellica IM Rub M QCSiemens Healthcare Diagnostics Inc.LFX2018-02-06
00630414600529Atellica IM Rub GSiemens Healthcare Diagnostics Inc.LFX2018-02-06
00630414600536Atellica IM Rub G QCSiemens Healthcare Diagnostics Inc.LFX2018-02-06
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