FDA.report

BioPlex 2200

Primary DI
00847865013000
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
SW4.1V1
Catalog number
6652365A
Device description
Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1
Published
2020-01-30
Public version status
New
Distribution status
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
MVMAutoantibodies, endomysial(tissue transglutaminase)

Product Code Classifications

CodeDeviceSpecialtyClass
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)Immunology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847865013000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865013000008478650130008478650130000847865013000

GMDN Terms

TermDefinition
Multiple Coeliac disease-associated antibody IVD, kit, multiplexA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with Coeliac disease in a clinical specimen, using a multiplex method. These antibodies may include autoimmune antibodies directed at gliadin (anti-gliadin IgA or IgG), endomysium (anti-endomysial antibodies), immunoglobulin A (anti-IgA) and/or tissue transglutaminase antibodies (anti-tTG).

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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