L.pneu 1-6/bdglmj/C Specimen Slide

Primary DI
00813545023232
Brand
L.pneu 1-6/bdglmj/C Specimen Slide
Company
SCIMEDX CORPORATION
Model
7000C
Catalog number
7000C
Published
2016-09-20
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K822066000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K822066000LEGIONELLA PNEUMOPHILABiodan Medical Systems, Ltd.1982-09-21LHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813545023232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545023232008135450232328135450232320813545023232

GMDN Terms#

Term, Definition table
TermDefinition
Legionella pneumophila total antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002215598service@scimedx.com

Regulatory Flags#

DUNS number
155424708
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813545026905MeDiCa1001-481001-482020-11-04
00813545026912MeDiCa1001-961001-962020-11-04
00813545026561MeDiCa010101012020-12-01
00813545026578MeDiCa010201022020-12-01
00813545026776MeDiCa082108212020-12-01
00813545026783MeDiCa082208222020-12-01
00813545026790MeDiCa0821-M0821-M2020-12-01
00813545026806MeDiCa0822-M0822-M2020-12-01
00813545026813MeDiCa083108312020-12-01
00813545026820MeDiCa083208322020-12-01
00813545026837MeDiCa0831-M0831-M2020-12-01
00813545026844MeDiCa0832-M0832-M2020-12-01
00813545026851MeDiCa083308332020-12-01
00813545026868MeDiCa0833-M0833-M2020-12-01
00813545026875MeDiCa083408342020-12-01
00813545026882MeDiCa0834-M0834-M2020-12-01
00813545026899MeDiCa0842-RM0842-M2020-12-01
00813545027223MeDiCa8021-488021-482020-12-01
00813545027261MeDiCa8021-4008021-4002020-12-01
00813545027278MeDiCa8021-96-GI8021-96-GI2020-12-01

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