FDA.reportPublic FDA data

LifeSign® MI StatusFirst CK-MB/Myo/TnI card

Primary DI
10743816001331
Brand
LifeSign® MI StatusFirst CK-MB/Myo/TnI card
Company
PRINCETON BIOMEDITECH CORPORATION
Model
LSC-300-20-02
Catalog number
LSC-300-20-02
Device description
LifeSign® MI StatusFirst CK-MB/Myo/TnI; 20 Test kit; CE
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DEAMyoglobin, Fitc, Antigen, Antiserum, Control
JHTChromatographic Separation, Cpk Isoenzymes
MMIImmunoassay Method, Troponin Subunit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DEAMyoglobin, Fitc, Antigen, Antiserum, ControlImmunology2
JHTChromatographic Separation, Cpk IsoenzymesClinical Chemistry2
MMIImmunoassay Method, Troponin SubunitClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981882000CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TESTPrinceton BioMeditech Corp.1998-07-06MMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10743816001331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1074381600133110743816001331

GMDN Terms#

Term, Definition table
TermDefinition
Troponin I IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of troponin I in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005262125info@lifesignmed.com

Regulatory Flags#

DUNS number
362917692
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
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10743816001621Status™ COVID-19 Antigen Rapid Test for Home UseBSP-512-01-00BSP-512-01-002023-10-20
10743816001638Status™ COVID-19 Antigen Rapid Test for Home UseBSP-512-02-00BSP-512-02-002023-10-20
10743816001645Status™ COVID-19 Antigen Rapid Test for Home UseBSP-512-25-00BSP-512-025-002023-10-20
10743816000532BioSign® hCG cardBSP-121-35-00BSP-121-35-002016-09-23
10743816000556Status hCG cardBSP-121-35-01BSP-121-35-012016-09-23
10743816000563Status hCG cardBSP-121-12-00BSP-121-12-002016-09-23
10743816000570BioSign® hCG cardBSP-121-35-03BSP-121-35-032016-09-23
10743816000587BioSign® hCG cardBSP-121-10-01BSP-121-10-012016-09-23
10743816000594Status hCG cardBSP-121-35-06BSP-121-35-062016-09-23
10743816000600BioSign® hCG cardBSP-121-35-07BSP-121-35-072016-09-23
10743816000617BioSign® hCG cardBSP-121-35-10BSP-121-35-102016-09-23
10743816000624Status hCG controlsBSP-121C-00BSP-121C-002016-09-23
10743816000631Status™ hCG S/U cardBSP-120S-35-01BSP-120S-35-012016-09-23
10743816000648Status™ hCG S/U cardBSP-120S-12-00BSP-120S-12-002016-09-23
10743816000655BioSign® hCG S/U cardBSP-120S-35-04BSP-120S-35-042016-09-23
10743816000662BioSign® hCG S/U cardBSP-120S-10-01BSP-120S-10-012016-09-23
10743816000679BioSign® hCG S/U cardBSP-120S-35-09BSP-120S-35-092016-09-23
10743816000686Status™ hCG S/U cardBSP-120S-10-03BSP-120S-10-032016-09-23
10743816000693StatusFirst™ hCG S/U cardBSP-122-35-02BSP-122-35-022016-09-23

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