FDA.reportPublic FDA data

Fungal Immunodiffusion Plates - 1 Series

Primary DI
00840733101403
Brand
Fungal Immunodiffusion Plates - 1 Series
Company
MERIDIAN BIOSCIENCE, INC.
Model
101012
Catalog number
101012
Device description
For the detection of circulating antibody to common systemic pathogens.
Published
2019-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JZQPlates And Equipment, Radial Immunodiffusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZQPlates And Equipment, Radial ImmunodiffusionImmunology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K792699000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K792699000OUCHTERLONY AGAR PLATESMeridian Diagnostics, Inc.1980-01-24JZQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101403008407331014038407331014030840733101403

GMDN Terms#

Term, Definition table
TermDefinition
Multiple fungi exoantigen IVD, kit, precipitation/immunodiffusionA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple exoantigens from fungal species, which may include Histoplasma capsulatum, Blastomyces dermatitidis and/or Coccidioides immitis in a clinical specimen, using a precipitation/immunodiffusion method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092815364
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
00840733101595StatID PRO COVID/Flu A&B Swabs7831107831102026-05-14
00840733101557statID Pro COVID-19/Flu External Controls7830102026-04-10
00840733101564statID Pro COVID-19/Flu A&B7830252026-04-10
00840733101717PREMIER CAMPY6180966180962020-09-01
00840733101397Fungal Immunodiffusion Plates - 4 Series1010091010092019-11-21
00840733101014ANA Screen ELISA Test Kit488426148842612016-09-23
00840733102585Hemo-De8013008013002020-12-09
00840733102660Modified Hemo-De8016008016002020-09-21
00840733102318Revogene6102106102102020-07-15
00840733102547EcoStain8014008014002020-12-09
00840733102394SpinCon9722009722002020-10-26
00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
00840733102714Para-Pak C&S9006129006122020-12-09
00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09
00840733102493Para-Pak Ultra EcoFix9813129813122020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840733101397Fungal Immunodiffusion Plates - 4 SeriesMERIDIAN BIOSCIENCE, INC.JZQ2019-11-21
B1761024IgA RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761025IgA RID plate KitKENT LABORATORIES INCJZQ2016-09-24
B1761065C-3 Proactivator RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761094C-4 (b1e) RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761095C-4 (b1e) RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761104C-5 (b1f) RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761105C-5 (b1f) RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761114C1q RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761115C1q RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761124Haptoglobin RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761125Haptoglobin RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761224Alpha 1 Antitrypsin RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761225Alpha 1 Antitrypsin RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761234Alpha 1 Acid Glycoprotein RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761235Alpha 1 Acid Glycoprotein RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761244Alpha 2 Macroglobulin RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761245Alpha 2 Macroglobulin RID kitKENT LABORATORIES INCJZQ2016-09-24
B1761254Transferrin RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761255Transferrin RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761264Ceruloplasmin RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761265Ceruloplasmin RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761274IgD RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761275IgD RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761344C Reactive Protein RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761345C Reactive Protein RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761354C1 Esterase Inhibitor RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761355C1 Esterase Inhibitor RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761494Hemopexin RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761544Prealbumin RID plate packageKENT LABORATORIES INCJZQ2016-09-24