FDA.report

Hgb Control, Low

Primary DI
00657498002018
Brand
Hgb Control, Low
Company
STANBIO LABORATORY, L.P.
Model
3060-101L
Catalog number
3060-101L
Device description
A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system.
Published
2018-02-21
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
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00657498002018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498002018006574980020186574980020180657498002018

GMDN Terms

TermDefinition
Total haemoglobin (totHb) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags

DUNS number
045361136
Device count
1
DM exempt
false
Premarket exempt
true
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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