FDA.report

BioPlex 2200

Primary DI
00847865000604
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
6651950
Catalog number
6651950
Device description
APLS IgG 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
MIDSYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
MIDSystem, Test, Anticardiolipin ImmunologicalImmunology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847865000604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865000604008478650006048478650006040847865000604

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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