FDA.reportPublic FDA data

PR 4100

Primary DI
03610520013571
Brand
PR 4100
Company
BIO-RAD
Model
91587
Catalog number
91587
Device description
PR 4100
Published
2023-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJQCOLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610520013571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610520013571036105200135713610520013571

GMDN Terms#

Term, Definition table
TermDefinition
Enzyme immunoassay (EIA) analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers, in a clinical specimen, using an immunological method which utilizes an enzyme-based detection system with sample processing, data processing and/or data display software. It uses enzyme-labelled antigens or antibodies and a solid-phase binding support (e.g., beads, microplates) to measure the substance of interest, typically antigens, antibodies, drugs, or endogenous substances in body fluids.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723TechSupport-Redmond@Bio-Rad.com

Regulatory Flags#

DUNS number
269902602
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610522220526Platelia12015253120152532023-07-03
03610520002933Select63747637472016-08-16
03610520007860PLATELIA25296252962016-08-16
03610520007877PLATELIA25297252972016-08-16
03610522220519Platelia12015289120152892023-07-03
03610520010785GEENIUS92465924652023-02-03
03610520013328EVOLIS89601896012023-02-03
03610520014103BIO-RAD87530875302023-02-03
03610522189380Platelia12014064120140642023-01-08
03610520002940Select63748637482023-01-05
03610520034309Select63740637402023-01-05
03610520000953Pastorex56353563532022-12-22
03610520000960Pastorex56356563562022-12-22
03610520002490Platelia62786627862022-12-22
03610520002902Select63726637262022-12-22
03610520002919Select63727637272022-12-22
03610520002971Select63751637512016-08-16
03610520007853PLATELIA26211262112016-08-16
03610520013847Geenius 72461724612015-01-12
03610520013854Geenius723392015-01-12

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Primary DI, Brand, Company table
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00860011967750ZELLECHEM 200STERILE SAFEQUIP & CHEMICALS LLPJJQ2024-10-01
00816467020396FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
00816467020402FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
00816870020006NeoLumax CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
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00816870020068PrisMatic ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
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07290016923063Auto Sampler (for BreathID Hp Lab System)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923384BreathID Hp Lab DeviceMERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923391BreathID Hp Lab Device (WIN)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
00860011967743ZELLECHEM-PROSTERILE SAFEQUIP & CHEMICALS LLPJJQ2024-07-09
04048474052527DRG:HYBRiD.XL®DRG Instruments Gesellschaft mit beschränkter HaftungJJQ2023-09-02
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10810138822705EndocatorEndo Direct LLCJJQ2023-07-16
09120052071184SUNRISETecan Austria GmbHJJQ2023-07-06
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09120052071207SUNRISE-RC/TW EVOLYZERTecan Austria GmbHJJQ2023-07-06
09120052071214SUNRISE-RC/6F EVOLYZERTecan Austria GmbHJJQ2023-07-06
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06936895300212BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
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00850229007010StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05