FDA.reportPublic FDA data

NA

Primary DI
00848838028793
Brand
NA
Company
REMEL, INC.
Model
R30851501
Device description
Cryptococcus LTX Antigen Test 50TST/KT
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838028793PrimaryGS10
00848838099861Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838028793008488380287938488380287930848838028793
00848838099861008488380998618488380998610848838099861

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002556730ITechnicalSupport@remel.com
8002556730csemail@thermofisher.com

Regulatory Flags#

DUNS number
065769564
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848838018855NACP114-102016-09-24
00848838031274REMELR40041R400412023-01-03
00842558116709Spectra™ Candida Agar R018332026-02-09
00848838072772MicroTest M6R12582R125822022-12-22
00848838074844MicroTest M4RTR12567R125672022-12-22
00848838075018MicroTest M6R12560R125602022-12-22
00848838091827NA7115-602022-04-21
00848838091742VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-302025-01-16
00848838091834NA7116-702016-12-09
00848838003158Strep Selective II AgarR018592026-01-16
00848838059865^BM^ PK/50 OXIDASE TESTR90556352026-01-16
00848838066856Liquid Amies,Dual Swab PK/50R7230952025-06-18
00848838066887Liquid Stuarts,Single Swab PK/500R7231102025-06-18
00848838066894Liquid Stuarts,Single Swab PK/50R7231152025-06-18
00848838066900Liquid Stuarts,Dual Swab PK/500R7231202025-06-18
00848838066917Liquid Stuarts,Dual Swab PK/50R7231252025-06-18
00848838066924Liquid Stuarts,Wire Shaft Swab PK/100R7231302025-06-18
00848838066931Liquid Stuarts,Wire Shaft PK/50R7231352025-06-18
00848838011177Sensititre Demineralized WaterT33392023-12-21
00842558105611^CE^Liq Stuarts,Dual Swab 36mmPK/500r97231202025-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838026966NAOXOID LIMITEDGMD2016-09-24
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
00840733101083CALAS PronaseMERIDIAN BIOSCIENCE, INC.GMD2016-09-23
00840733101090Cryptococcal Antigen Latex Agglutination System (CALAS)MERIDIAN BIOSCIENCE, INC.GMD2016-09-23