FDA.report

BioPlex 2200

Primary DI
00847865000628
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
6632000
Catalog number
6632000
Device description
APLS IgM Calibrator Set
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
JIXCALIBRATOR, MULTI-ANALYTE MIXTURE

Product Code Classifications

CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847865000628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865000628008478650006288478650006280847865000628

GMDN Terms

TermDefinition
Phospholipid IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of one or multiple phospholipids in a clinical specimen.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Total Volume0.5Milliliter

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03610522231072Liquichek12015644120156442024-05-24
03610522231089Liquichek12015645120156452024-05-24
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10673486014013Teco Diagnostics Chemistry CalibratorTECO DIAGNOSTICSJIX2026-03-20
03701700817802ELICAL 2 VITALSCIENTIFICJIX2026-03-04
05430003908648SEEKER®Lacar MDX TechnologiesJIX2026-01-15
05430003908655SEEKER®Lacar MDX TechnologiesJIX2026-01-15
05430003908662SEEKER®Lacar MDX TechnologiesJIX2026-01-15
05430003908679SEEKER®Lacar MDX TechnologiesJIX2026-01-15
04250317554994Plasma Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2025-07-31
07613336232156Ionify CalSet Steroids and Vitamin DRoche Diagnostics GmbHJIX2025-06-25
00850053916267IDG/SanzayIDG/SANZAY CorporationJIX2024-07-03
08430793040761Aptiva® APS IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2024-03-11
08430793040907Aptiva® APS IgM CalibratorsINOVA DIAGNOSTICS, INC.JIX2024-03-11
00630414304915Atellica CH Prot2 CALSiemens Healthcare Diagnostics Inc.JIX2024-02-02
04580262010314Calibrator 2TOKYO BOEKI MEDISYS INC.JIX2023-12-18
08430793040181Aptiva® CTD Essential CalibratorsINOVA DIAGNOSTICS, INC.JIX2023-12-14
00816776020544MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020568MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020582MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020599MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
10852676007060Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2023-08-09
00811403011087CO2 Alkaline BufferDiamond Diagnostics Inc.JIX2023-06-05
00816776020247MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-12-22
00817302024494CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 1 DT908CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00817302024500CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 2 DT909CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00817302024517CAROLINA LIQUID CHEMISTRIES CORP.® ISE SELECTIVITY CHECK DT910CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00380740164973ARCHITECTABBOTT IRELANDJIX2022-07-12
00380740164980AlinityABBOTT IRELANDJIX2022-07-12
04250317551115Urine Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2022-07-08
04250317552365Saliva Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2022-06-21
00816776020513MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-04-05
00816776020537MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-04-05