FDA.reportPublic FDA data

MONOFLUO

Primary DI
00847865001519
Brand
MONOFLUO
Company
Bio-RAD Laboratories, Inc.
Model
32515
Catalog number
32515
Device description
MONOFLUO Pneumocystis jirovecii (P. carinii) IFA Test
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYFPNEUMOCYSTIS CARINII

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYFPneumocystis CariniiMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K890768000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K890768000PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KITGenetic Systems Corp.1989-03-21LYF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865001519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865001519008478650015198478650015190847865001519

GMDN Terms#

Term, Definition table
TermDefinition
Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from the fungus Pneumocystis jirovecii (formerly known as P. carinii) in a clinical specimen, using a direct fluorescent test (DFT).

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723TechSupport.USSD-Redmond@bio-rad.com

Regulatory Flags#

DUNS number
844766394
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053252730351Light Diagnostics PCP DFA ReagentEMD Millipore CorporationLYF2020-04-17
04053252401121Light Diagnostics™ Pneumocystis Carinii DFA EMD Millipore CorporationLYF2016-09-26
00840733101106MERIFLUOR PneumocystisMERIDIAN BIOSCIENCE, INC.LYF2016-09-23
00847865001502MONOFLUOBio-RAD Laboratories, Inc.LYF2016-09-12