FDA.reportPublic FDA data

Kallestad

Primary DI
00847865001496
Brand
Kallestad
Company
Bio-RAD Laboratories, Inc.
Model
32514
Catalog number
32514
Device description
MONOFLUO Legionella pneumophila IFA Test Kit
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
LHLREAGENTS, ANTIBODY, LEGIONELLA, DIRECT & INDIRECT FLUORESCENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHLReagents, Antibody, Legionella, Direct & Indirect FluorescentMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865001496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865001496008478650014968478650014960847865001496

GMDN Terms#

Term, Definition table
TermDefinition
Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA), immunoglobulin G (IgG) and/or immunoglobulin M (IgM) antibodies to one or multiple serogroups of Legionella pneumophila in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease.

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
10628429001674Legionella pneumophila Serogroup 2 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001681Legionella pneumophila Serogroup 3 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001698Legionella pneumophila Serogroup 4 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001704Legionella pneumophila Serogroup 5 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001711Legionella pneumophila Serogroup 6 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001728Legionella micdadei DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001735Phosphate Buffered Saline (pH 7.6)PRO-LAB, INCORPORATEDLHL2022-12-25
10628429001759Legionella DFA Negative ControlPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001766Prolex Legionella pneumophila Serogroup 2 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001773Prolex Legionella pneumophila Serogroup 3 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001780Prolex Legionella pneumophila Serogroup 4 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001797Prolex Legionella pneumophila Serogroup 5 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001803Prolex Legionella pneumophila Serogroup 6 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001810Prolex Legionella micdadeiPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001827Prolex Legionella pneumophila Negative Control Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001834Legionella pneumophila Serogroup 1 DFA Kit (50 tests)PRO-LAB, INCORPORATEDLHL2022-12-25
10628429001841Legionella pneumophila Serogroups 1-14 DFA Kit (50 tests)PRO-LAB, INCORPORATEDLHL2022-12-25
10628429001858Legionella pneumophila Serogroup 7 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001865Legionella pneumophila Serogroup 8 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001872Legionella pneumophila Serogroup 9 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001889Legionella pneumophila Serogroup 10 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001896Legionella pneumophila Serogroup 11 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001902Legionella pneumophila Serogroup 12 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001919Legionella pneumophila Serogroup 13 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001926Legionella pneumophila Serogroup 14 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001933Legionella pneumophila Positive Control Serogroups 1-14PRO-LAB, INCORPORATEDLHL2022-12-25
10628429002015Prolex Legionella pneumophila Serogroup 7 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429002022Prolex Legionella pneumophila Serogroup 8 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429002039Prolex Legionella pneumophila Serogroup 9 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429002046Prolex Legionella pneumophila Serogroup 10 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25