SALI-TUBES 500 SLV-4157

GUDID 00404847441574

Sampling tubes for collection of saliva samples to be used in the DRG Salivary Immunoassays

DRG Instruments Gesellschaft mit beschränkter Haftung

General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive General specimen collection kit IVD, no additive
Primary Device ID00404847441574
NIH Device Record Key9ca1b542-4ada-4ed9-9771-ad187d05ea78
Commercial Distribution StatusIn Commercial Distribution
Brand NameSALI-TUBES 500
Version Model NumberSLV-4157
Catalog NumberSLV-4157
Company DUNS317134468
Company NameDRG Instruments Gesellschaft mit beschränkter Haftung
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100404847441574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JLSRADIOIMMUNOASSAY, PROGESTERONE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-15
Device Publish Date2021-06-07

Devices Manufactured by DRG Instruments Gesellschaft mit beschränkter Haftung

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04048474030136 - Salivary Testosterone ELISA2023-09-11 The Salivary Testosterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active tes
04048474031409 - Salivary 17-OH Progesterone ELISA2023-09-11 An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-a-hydroxyprogesterone in saliva.
04048474041880 - Salivary Estradiol ELISA 2023-09-11 Enzyme immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in sali
04048474051001 - α1-Microglobulin ELISA2023-09-11 The Assay is intended for the quantitative determination of a1-Microglobulin in serum, plasma and urine.
04048474051889 - Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA2023-09-11 The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitative determination of IgG class antibodies against
04048474051896 - Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA2023-09-11 The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against
04048474052527 - DRG:HYBRiD.XL®2023-09-11 The DRG:HYBRiD-XL® is a fully automated random access analyzer.

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