FDA.report

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
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KHEReagent, Occult Blood

Product Code Classifications

CodeDeviceSpecialtyClass
KHEReagent, Occult BloodHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00657498129012PrimaryGS10
00657498129029Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498129012006574981290126574981290120657498129012
00657498129029006574981290296574981290290657498129029

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags

DUNS number
045361136
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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