Cryptococcal Antigen Latex Agglutination System (CALAS)

Primary DI
00840733101090
Brand
Cryptococcal Antigen Latex Agglutination System (CALAS)
Company
MERIDIAN BIOSCIENCE, INC.
Model
140100
Catalog number
140100
Device description
The Cryptococcal Antigen Latex Agglutination System (CALAS) is a qualitative and semiquantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrospinal fluid (CSF).
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
00840733101090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101090008407331010908407331010900840733101090

GMDN Terms#

Term, Definition table
TermDefinition
Cryptococcus neoformans antigen IVD, kit, agglutination, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from the yeast Cryptococcus neoformans in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an agglutination method. This test is commonly used in the laboratory or in point-of-care analyses.

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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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838026966NAOXOID LIMITEDGMD2016-09-24
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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
00840733101083CALAS PronaseMERIDIAN BIOSCIENCE, INC.GMD2016-09-23