Cand-Tec

Primary DI
28600000686028
Brand
Cand-Tec
Company
Ramco Laboratories, Inc.
Model
CO3/2
Catalog number
CO3/2
Device description
Candida Detection
Published
2019-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LHKANTIGEN, ID, CANDIDA ALBICANS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHKAntigen, Id, Candida AlbicansMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K823016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K823016000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28600000686028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2860000068602828600000686028

GMDN Terms#

Term, Definition table
TermDefinition
Candida albicans/C. tropicalis/C. parapsilosis 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 species Candida albicans, Candida tropicalis and/or Candida parapsilosis 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
+1(281)313-1200ramcolab@aol.com

Regulatory Flags#

DUNS number
082013897
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18600000686021Cand-TecCO3/1CO3/12019-03-26
78600000686023Cand-TecCO3/7CO3/72019-03-26
08600000686024Cand-TecCO3/5CO3/52019-03-23
08600000686031TfRTFC-94TFC-942019-03-26
08600000686048VFEVE-98VE-982019-03-26
08600000686017Spectro Ferritin MTS-22S-222019-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18600000686021Cand-TecRamco Laboratories, Inc.LHK2019-03-26
78600000686023Cand-TecRamco Laboratories, Inc.LHK2019-03-26
08600000686024Cand-TecRamco Laboratories, Inc.LHK2019-03-23