FDA.reportPublic FDA data

Anti-Histoplasma Control Serum (Goat) for Immunodiffusion

Primary DI
00840733101052
Brand
Anti-Histoplasma Control Serum (Goat) for Immunodiffusion
Company
MERIDIAN BIOSCIENCE, INC.
Model
100601
Catalog number
100601
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
2016-09-22
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
GMKAntiserum, Positive Control, Histoplasma Capsulatum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMKAntiserum, Positive Control, Histoplasma CapsulatumMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K792679000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K792679000HISTOPLASMA CAPSULATUM, ANTISERUMMeridian Diagnostics, Inc.1980-01-17GMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101052008407331010528407331010520840733101052

GMDN Terms#

Term, Definition table
TermDefinition
Histoplasma capsulatum antigen IVD, controlA material which is used to verify the performance of an assay intended to be 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

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Primary DI, Brand, Model table
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00840733101717PREMIER CAMPY6180966180962020-09-01
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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
00816387020353IMMYImmuno-Mycologics, Inc.GMK2016-09-24
00816387020384IMMYImmuno-Mycologics, Inc.GMK2016-09-24
00816387020407IMMYImmuno-Mycologics, Inc.GMK2016-09-24
10634853000114Fungal SerologyMICROBIOLOGICS INC.GMK2016-09-15
10634853000121Fungal SerologyMICROBIOLOGICS INC.GMK2016-09-15