Histoplasma Antigen for Fungal Immunodiffusion

Primary DI
00840733101021
Brand
Histoplasma Antigen for Fungal Immunodiffusion
Company
MERIDIAN BIOSCIENCE, INC.
Model
100201
Catalog number
100201
Device description
Histoplasma capsulatum antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Histoplasma capsulatum (H. cap.). These reagents are optimized for use in the Ouchterlony double diffusion.
Published
2016-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GMJAntigens, Histoplasma Capsulatum, All

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMJAntigens, Histoplasma Capsulatum, AllMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K792701000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K792701000HISTOPLASMA CAPSULATUM, ANTIGENMeridian Diagnostics, Inc.1980-01-23GMJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101021008407331010218407331010210840733101021

GMDN Terms#

Term, Definition table
TermDefinition
Histoplasma capsulatum antigen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from the fungus Histoplasma capsulatum in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
513-271-3700info@meridianbioscience.com

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
00840733101403Fungal Immunodiffusion Plates - 1 Series1010121010122019-11-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816387020339IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020346IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020360IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020377IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020391IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020599IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020605IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020841IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020858IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
10634853000091Fungal SerologyMICROBIOLOGICS INC.GMJ2016-09-15
10634853000107Fungal SerologyMICROBIOLOGICS INC.GMJ2016-09-15