FDA.reportPublic FDA data

CALAS Pronase

Primary DI
00840733101083
Brand
CALAS Pronase
Company
MERIDIAN BIOSCIENCE, INC.
Model
140050
Catalog number
140050
Device description
CALAS Pronase is a serum pretreatment reagent for use with Cryptococcal Antigen Latex Agglutination System (CALAS).
Published
2016-09-23
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
GMDAntisera, Latex Agglutination, Cryptococcus Neoformans

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMDAntisera, Latex Agglutination, Cryptococcus NeoformansMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894845000(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASEMeridian Diagnostics, Inc.1989-09-08GMD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101083008407331010838407331010830840733101083

GMDN Terms#

Term, Definition table
TermDefinition
Cryptococcus neoformans 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 yeast Cryptococcus neoformans 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
00848838026966NAOXOID LIMITEDGMD2016-09-24
00848838028793NAREMEL, INC.GMD2016-09-24
00848838080913NAREMEL, INC.GMD2016-09-24
00816387020292IMMYImmuno-Mycologics, Inc.GMD2016-09-24
00816387020322IMMYImmuno-Mycologics, Inc.GMD2016-09-24
00816387020827IMMYImmuno-Mycologics, Inc.GMD2016-09-24
00816387020834IMMYImmuno-Mycologics, Inc.GMD2016-09-24
00816387020872IMMYImmuno-Mycologics, Inc.GMD2016-09-24
00816387020919IMMYImmuno-Mycologics, Inc.GMD2016-09-24
00840733101090Cryptococcal Antigen Latex Agglutination System (CALAS)MERIDIAN BIOSCIENCE, INC.GMD2016-09-23