FDA.reportPublic FDA data

Hema-Screen Lab Pack

Primary DI
00657498129012
Brand
Hema-Screen Lab Pack
Company
STANBIO LABORATORY, L.P.
Model
1290-100
Catalog number
1290-100
Device description
Hema-Screen is a guaiac slide test for the qualitative detection of fecal occult blood.
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
KHEReagent, Occult Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHEReagent, Occult BloodHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00657498129012PrimaryGS10
00657498129029Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498129012006574981290126574981290120657498129012
00657498129029006574981290296574981290290657498129029

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, kit, chromogenic, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin) within a short period relative to standard laboratory testing procedures, using a chromogenic method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
045361136
Device count
100
Lot or batch
true
Expiration date on label
true

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00657498000427Acetaminophen Liquicolor®2400-0602400-0602016-09-23
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00657498000496AST/SGOT Liqui-UV®2920-4302920-4302016-09-23
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