FDA.reportPublic FDA data

Spermac Stain - Stain C (250ml)

Primary DI
05411967001606
Brand
Spermac Stain - Stain C (250ml)
Company
Fertipro NV
Model
SPS250C
Device description
Spermac Stain is a qualitative diagnostic kit for staining human spermatozoa. The purpose of staining spermatozoa is to be able to differentiate morphologically normal from abnormal sperm cells.For more information, visit the FertiPro website: www.fertipro.com
Published
2018-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LEDStains, Chemical Solution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEDStains, Chemical SolutionHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05411967001606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05411967001606054119670016065411967001606

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume250Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3250791805info@fertipro.com

Regulatory Flags#

DUNS number
373904101
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05411967001347SpermMar Test IgA - complete kitSPMA_C2026-05-06
05411967000036SpermMar Test IgG - single kitSPMG_S2018-08-22
05411967001354SpermMar Test IgG - Complete kitSPMG_C2019-02-01
05411967002566SpermMar Test IgA - single kitSPMA_S2018-08-22
05411967003464InActiv BlueIB_TUB2024-08-14
05411967003471InActiv BlueIB_TUB2024-08-14
05411967001392SpermFreeze SSPSSP0202020-05-04
05411967001408SpermFreeze SSPSSP1252020-04-30
05411967002023SpermFreeze SSPSSP0012020-05-04
05411967003440SpermFreeze SSPSSP62.52021-07-06
05411967005697SpermFreeze SSPSSP0502023-02-28
05411967000098Sil-Select StockSIS1002016-09-19
05411967001316Sil-Select StockSIS100_322016-09-19
05411967001323Sil-Select StockSIS5002016-09-19
05411967002016SpermFreezeSPF052016-05-24
05411967000869FertiCult Mineral OilMINOIL100P2018-11-06
05411967000883FertiCult Mineral OilMINOIL500P2018-11-06
05411967000890FertiCult Mineral OilMINOIL050P2018-11-06
05411967002009SpermFreezeSPF2016-05-19
05411967000067FertiCult Mineral OilMINOIL050 2016-09-19

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