FDA.reportPublic FDA data

Spermac Stain - 4x 50ml

Primary DI
54119670002038
Brand
Spermac Stain - 4x 50ml
Company
Fertipro NV
Model
SPS050
Device description
Spermac Stain is a qualitative diagnostic kit for staining human spermatozoa. The purpose of staining spermatozoa is to be able to differentiate morph
Published
2018-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
54119670002038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5411967000203854119670002038

GMDN Terms#

Term, Definition table
TermDefinition
Papanicolaou/Pap stain IVD, kitA collection of chemical agents, dyes and/or other associated materials referred to as a Papanicolaou stain or Pap stain, intended to be used for the demonstration of exfoliated cells in biological/clinical specimens, which may include gynaecological smears (sometimes referred to as Pap smears), sputum, brushings, washings, urine, and/or fine needle aspirates.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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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Primary DI, Brand, Company table
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